Acute Respiratory Failure

40

Review clinical trials related to Acute Respiratory Failure. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Simulation Trial of Telemedical Support for Paramedics

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

Participants needed: 420
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: Boston Medical CenterUpdated: Jun 30, 2026Locations: 9
Eligibility criteria

Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Param... [+2]

EMS personnel providing interfacility transport and/or pediatric specialty trans... [+2]

Status: Recruiting

Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

Mechanically ventilated intensive care patients will be sampled for a small amount of exhaled breath condensate from the ventilator circuit and for venous blood. Proteomic analysis of the exhaled breath condensate will be performed using mass spectrometry and in the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied. Resulting profiles will be correlated with routinely monitored parameters in order to identify patterns corresponding to various pathologies in order to enable their early detection.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The Institute of Molecular and Translational Medicine, Czech RepublicUpdated: Jun 25, 2026Locations: 2
Eligibility criteria

Not listed

Status: Recruiting

Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure

Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications. After the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1/3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT). Although the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings. Maintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose. the investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and/or acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.

Participants needed: 212
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Strasbourg, FranceUpdated: Jun 5, 2026Locations: 1
Eligibility criteria

- Adult patients, aged 18 years-old and over, [+7]

Minor patients, [+6]

Status: Recruiting

Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.

Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio. In adults, protocols for assessing perfusion distribution require the injection of 10 mL of a 7.5% or 10% NaCl solution or sodium bicarbonate over a few seconds. Studies have reported good hemodynamic tolerance, adequate image quality, and no significant changes in serum sodium levels. However, this volume and sodium load are not appropriate for small children. To date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation/perfusion ratio using EIT. It is therefore proposed to conduct a pilot study to evaluate the feasibility of assessing pulmonary perfusion by EIT using a weight-adjusted bolus of hypertonic saline (NaCl or sodium bicarbonate).

Participants needed: 20
Trial details
Age: Up to 12Biological sex: AllType: InterventionalSponsor: Hospices Civils de LyonUpdated: May 19, 2026Locations: 1
Eligibility criteria

patients < 12 years hospitalized in pediatric intensive care [+4]

Patients with significant leaks > 20% around the endotracheal tube [+10]

Status: Recruiting

Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.

Participants needed: 2,092
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Brian DriverUpdated: May 11, 2026Locations: 9
Eligibility criteria

Patient is located in a participating unit (ED or ICU) [+2]

Patient is known to be a prisoner [+2]

Status: Not yet recruiting

Diaphragm Response in Elderly for Acute Monitoring

Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.

Participants needed: 145
Trial details
Age: 75+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier de BethuneUpdated: May 6, 2026Locations: 9
Eligibility criteria

Patients aged ≥ 75 years [+2]

Acute respiratory distress requiring immediate invasive or non-invasive ventilat... [+11]

Status: Recruiting

Brain-lung Interaction During Acute Respiratory Failure

Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC. Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients. The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC. Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected. From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG. These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: May 1, 2026Locations: 2
Eligibility criteria

- Age ≥ 18 years [+6]

- Exacerbation of an underlying chronic respiratory disease [+8]

Status: Recruiting

A Clinical Study for Developing Artificial Intelligence(AI)-Based Clustering Model for Personalized Medicine in Acute Respiratory Failure

The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Samsung Medical CenterUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Age 18 or older [+1]

Patients 48 hours after oxygen treatment (HFNC, NIV (BIPAP or CPAP), MV) [+2]

Status: Recruiting

The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study

The goal of this observational pilot study is to learn if sodium bicarbonate can be used safely and effectively as a contrast agent to map lung blood flow using electrical impedance tomography (EIT) in adults on mechanical ventilation. Electrical impedance tomography (EIT) is a bedside imaging method that uses a soft belt with small sensors around the chest to track changes in electrical signals related to breathing and blood flow. The main questions are: Does sodium bicarbonate create clear, readable lung blood flow images with EIT? Are these images similar in quality and pattern to images made with hypertonic saline (10% sodium chloride)? Is the short-term safety profile acceptable, including effects on blood pressure, heart rhythm, and blood tests? Researchers will compare two contrast agents within the same participant to see if image quality and lung blood flow patterns match: Hypertonic saline (10% sodium chloride) Sodium bicarbonate (5%) Participants will: Have an EIT belt placed around the chest during routine ICU care Pause the ventilator briefly during image capture to reduce motion Receive two small intravenous boluses through an existing central line, one of hypertonic saline and one of sodium bicarbonate, with time between doses Have routine monitoring of vital signs; blood gases and electrolytes may be checked per clinical care Be observed for any short-term side effects Findings from this study will show whether sodium bicarbonate is a practical and safe option for EIT-based lung blood flow assessment and will guide larger future studies.

Participants needed: 41
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: First Affiliated Hospital of Wannan Medical CollegeUpdated: Apr 21, 2026Locations: 1Duration: 28 Days
Eligibility criteria

Age ≥ 18 years [+6]

Known pregnancy [+6]

Status: Recruiting

Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy

Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Laval UniversityUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

≥ 18 years of age [+3]

No SpO2 signal with oximeter in use [+4]

Status: Recruiting

Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.

Participants needed: 235
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Johns Hopkins UniversityUpdated: Feb 5, 2026Locations: 1
Eligibility criteria

≥18 years old [+7]

Pre-existing cognitive impairment (IQ-CODE >3.6) [+6]

Status: Recruiting

Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure

Electrical impedance tomography (EIT) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation. There are very few data in children admitted to the PICU (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the PICU (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,…)

Participants needed: 250
Trial details
Age: 0-18Biological sex: AllType: ObservationalSponsor: Hospices Civils de LyonUpdated: Jan 23, 2026Locations: 4
Eligibility criteria

children < 18 years [+7]

Monitor not available [+3]

Status: Recruiting

CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure

This observational study aims to evaluate the relationship between clinical and physiological variables and the failure of non-invasive respiratory support (NIRS), including high-flow nasal oxygen (HFNO) and non-invasive ventilation (NIV), in patients with acute respiratory failure (ARF), both hypoxemic and/or hypercapnic. The study includes both retrospective and prospective components. Retrospective data will be collected from patient charts, while prospective data will be collected at defined time points during clinical care. The primary outcome is NIRS failure, defined as the need for orotracheal intubation. Secondary outcomes include in-hospital and 90-day mortality, ICU and hospital length of stay, and duration of non-invasive and invasive support.

Participants needed: 325
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Modena and Reggio EmiliaUpdated: Jan 22, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+3]

Immediate need for invasive ventilation upon admission [+3]

Status: Not yet recruiting

Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia

This is a prospective, multicenter, interventional cohort study aimed at constructing a high-quality, dynamic multimodal database for patients with acute respiratory failure caused by community-acquired pneumonia (CAP-ARF). The study focuses on bacterial CAP-ARF patients receiving standardized glucocorticoid therapy to investigate the heterogeneity of treatment responses under different etiologies and immune statuses. The goal is to provide a data foundation for precise immune stratification and identification of glucocorticoid-sensitive populations.

Participants needed: 500
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Qingyuan ZhanUpdated: Jan 22, 2026
Eligibility criteria

Age ≥ 18 years. 2. Admitted to the Intensive Care Unit (ICU) within 48 hours. 3....

Suspected aspiration pneumonia. 2. Invasive mechanical ventilation within 14 day...

Status: Not yet recruiting

The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.

Participants needed: 1,200
Trial details
Age: Up to 90Biological sex: AllType: ObservationalSponsor: University of GenovaUpdated: Jan 20, 2026Duration: 1 Year
Eligibility criteria

All consecutive patients implanted with a veno-venous extracorporeal membrane ox...

Patients with incomplete data (primary endpoint and less than 80% secondary stud...

Status: Recruiting

Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure

Currently, there is no holistic solution for patients with respiratory diseases that includes oxygenation and management of a patient with respiratory disease, combining dynamic and automatic O2 administration and the detection of clinical worsening, generating a diagnostic suspicion, a management proposal, and notifying the medical team. For device validation, prospective studies will be conducted in patients in respiratory intermediate care units, conventional hospitalization, during physical activity in the hospital setting, and in an out-of-hospital setting. The device will be evaluated in terms of oxygenation efficacy, response time, patient safety, efficiency, versatility, clinical benefit, and adaptability.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Aether Tech S.L.Updated: Jan 9, 2026Locations: 2
Eligibility criteria

Men and women over 18 years of age. [+2]

Hemodynamic instability. [+4]

Status: Recruiting

Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound

Acute dyspnea is a common reason for emergency department (ED) admission and is frequently caused by acute heart failure with pulmonary edema. Rapid differentiation between cardiogenic and non-cardiogenic causes of dyspnea is essential to guide early treatment and risk stratification. However, no single gold standard exists for the assessment of venous congestion in the acute setting. This prospective observational study aims to evaluate the diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter measured by point-of-care ultrasound (POCUS) in identifying acute pulmonary edema in patients presenting to the ED with acute respiratory failure. In addition, the study investigates whether integration of IVC ultrasound with lung ultrasound, bedside cardiac ultrasound, and selected clinical and laboratory variables - such as hemoglobin and plasma protein changes - improves diagnostic performance and prognostic stratification.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Università degli Studi del Piemonte Orientale Amedeo AvogadroUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

Adults aged ≥18 years. [+5]

Refusal to provide informed consent (or consent by legal representative when app... [+4]

Status: Recruiting

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure. The main question it aims to answer is (study hypotheses): Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.

Participants needed: 20
Trial details
Age: Up to 8Biological sex: AllType: ObservationalSponsor: Xenios AGUpdated: Dec 24, 2025Locations: 2
Eligibility criteria

Informed consent signed and dated by parents or legal representative and investi... [+2]

Participation in an interventional clinical study during the preceding 30 days t... [+4]

Status: Recruiting

Virtual Reality in ICU - PARTNER

This project is designed to have patients participate in a virtual environment with various tasks such as breathing exercises, games to help the brain, and techniques that promote relaxation while hospitalized in the Intensive Care Unit (ICU). The participation in research will last about 5 days and take about 15 to 45 minutes each day.

Participants needed: 32
Trial details
Age: 18-99Biological sex: AllType: ObservationalSponsor: Kirby MayerUpdated: Oct 3, 2025Locations: 1
Eligibility criteria

Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis...

Are less than 18 years of age [+8]

Status: Recruiting

Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.

Participants needed: 1,036
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Hospital Clinico Universitario de SantiagoUpdated: Sep 15, 2025Locations: 29
Eligibility criteria

Age 18 years or older. [+3]

Pregnancy or lactation. [+3]

Status: Recruiting

Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure

The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival.

Participants needed: 450
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Pär JohanssonUpdated: Aug 22, 2025Locations: 5
Eligibility criteria

Adult intensive care patients (age ≥ 18 years) [+3]

Withdrawal from active therapy [+7]

Status: Recruiting

Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso

Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation \[3\]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries. Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.

Participants needed: 240
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Université NAZI BONIUpdated: Jul 28, 2025Locations: 4
Eligibility criteria

Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min [+1]

Pregnant or breastfeeding women [+8]

Status: Recruiting

External Validation of the BREF Models

Introduction High-flow oxygen therapy is increasingly used to treat acute respiratory failure (ARF). It can reduce intubation rates without increasing mortality. Moreover, it is better tolerated than other non-invasive respiratory support therapies. However, patients with ARF often make strong breathing efforts, which may cause several harm. They can fatigue the respiratory muscles. They can increase whole-body oxygen consumption and carbon dioxide production. They can cause pulmonary edema. They might also injure the diaphragm and the lungs. For all these reasons, strong breathing efforts should be recognized and treated. During spontaneous breathing, inspiratory muscle contractions produce parallel deflections of the pleural and esophageal pressure (ΔPes), which reflect the magnitude of the effort. Unlike changes in pleural pressure, ΔPes can be easily measured at the bedside using a catheter similar to a typical nasogastric tube. In healthy subjects, ΔPes is only a few cmH2O during quiet breathing but \>10-15 cmH2O during vigorous exercise or carbon dioxide inhalation. In patients with ARF, the upper limit for a "safe" ΔPes is unknown. Nonetheless, according to experts, breathing efforts with a ΔPes \>10-15 cmH2O are probably too strong to be tolerated for a long time. However, esophageal manometry is not widely available. Estimating breathing efforts without it is complex, especially in non-intubated patients. Doctors mostly rely on their gestalt or overall impression. Therefore, it is unsurprising that they may disagree when rating their patients' breathing efforts or debating whether to proceed to intubation. The investigators have recently developed two clinical prediction models for estimating the breathing effort of patients with ARF from a few variables readily available at the bedside. The first, "linear", model estimates the continuous value of ΔPes (in cmH2O) from the presence or absence of COVID-19, arterial base excess concentration (BEa) (in mmol/L), respiratory rate (in bpm), the ratio of the arterial tension to the inspiratory fraction of oxygen (PaO2:FiO2) (in mmHg), and the product term between COVID-19 and PaO2:FiO2. The calibration slope was 1, and the adjusted R2 was 0.39. The second, "logistic", model estimates the probability of ΔPes being \>10 cmH2O (dichotomous outcome) from BEa (in mmol/L), respiratory rate (in bpm), and PaO2:FiO2 (in mmHg). When this model was tested on the same data set used to develop it (apparent performance), the area under the ROC curve (AUROC) was 0.79 (95% CI, 0.73-0.85). At internal validation (optimism-corrected performance), the AUROC was 0.76 (0.71-0.81). The investigators called these models BREF, which stands for BReathing EFfort, but also to the three main predictors: BEa (B), respiratory rate (RE), and PaO2:FiO2 (F). Study aims The main goal of this study is to evaluate the BREF models' predictive performance in a new population. This process is known as "external validation". Additionally, there are two other secondary objectives. The investigators aim to update the BREF models by adding more variables unavailable in the development dataset (method "extension") and compare the accuracy of the BREF models with that of doctors who do not use them in assessing their patients' breathing efforts. Study population Inclusion criteria: * adult (≥18 years of age) patients in the ICU * treated with high-flow oxygen delivered via nasal cannula * equipped with an esophageal balloon as per local clinical practice. Exclusion criteria: * history of chronic lung disease * cardiogenic pulmonary edema * \>96 hours from admission to the participating unit. Methods First, participants will record all the variables needed to estimate ΔPes using the original version of the BREF models. These are the presence or absence of COVID-19, BEa, respiratory rate, PaO2:FiO2, and the product term between COVID-19 and PaO2:FiO2. Moreover, participants will record other variables that may help predict ΔPes based on scientific reasoning. Next, the attending doctor (blinded to the actual ΔPes) will assess the patient's breathing effort based on clinical judgment. Third, the actual ΔPes will be measured with esophageal manometry. Finally, the participants will record the type of respiratory support provided to the patient in the 72 hours following the study, the length of stay in the unit, and the vital status of the patient (dead or alive) at discharge from the unit. Sample size calculation This study aims to enroll 250 patients in approximately two years.

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Istituto Clinico HumanitasUpdated: Jul 4, 2025Locations: 1
Eligibility criteria

adult (≥18 years of age) patients in the ICU [+2]

history of chronic lung disease [+2]

Status: Recruiting

Improving Non-invasive Ventilation

A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.

Participants needed: 750
Trial details
Age: 18-99Biological sex: AllType: ObservationalSponsor: Università Vita-Salute San RaffaeleUpdated: Jul 1, 2025Locations: 1
Eligibility criteria

treatment with non-invasive ventilation [+1]

refusal of informed consent

Status: Recruiting

Inspiratory Effort in COVID-19

This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.

Participants needed: 40
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: University of Modena and Reggio EmiliaUpdated: Apr 25, 2025Locations: 1
Eligibility criteria

COVID-19 [+1]

Need for immediate endotracheal intubation [+1]