Non Invasive Ventilation

11

Review clinical trials related to Non Invasive Ventilation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator. For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

Participants needed: 100
Trial details
Biological sex: AllType: ObservationalSponsor: University Medical Center GroningenUpdated: Jul 2, 2026Locations: 1Duration: 6 Months
Eligibility criteria

COPD patients indicated for chronic home NIV

not able to read the written information and/or sign the informed consent form [+1]

Status: Recruiting

A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)

Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time. The investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day. In this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study. The purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.

Participants needed: 48
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: Jun 26, 2026Locations: 3
Eligibility criteria

Diagnosed with ALS using the Gold Coast Criteria within the last 6 months [+3]

Forced vital capacity <50% of predicted normal [+10]

Status: Not yet recruiting

VENTILATION DURING SPACEFLIGHT (PHASE 2)

Space flights expose astronauts to medical risks, particularly respiratory risks, which are exacerbated in microgravity. Devices such as standard oxygen therapy and non-invasive ventilation (NIV) are used, but their performance in microgravity remains poorly studied. Parabolic flights allow these technologies to be evaluated in conditions similar to those encountered during space missions. In an initial study conducted in microgravity during a parabolic flight campaign, the T1 ventilator proved superior to the other devices tested on the test bench. However, its performance in healthy volunteers has not yet been evaluated. The central hypothesis of this exploratory study on healthy volunteers is that non-invasive ventilation, particularly with the CaStar UP helmet (Intersurgical), could offer superior performance to the standard oxygen mask in microgravity, thanks to better leak reduction (data from preclinical work on a test bench).

Participants needed: 12
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Régional Metz-ThionvilleUpdated: Jun 25, 2026Locations: 1
Eligibility criteria

Healthy volunteers (male or female) [+6]

Individuals who have participated in a previous biomedical research protocol [+7]

Status: Recruiting

Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients on Non Invasive Respiratory Support

Acute respiratory failure is a common, life-threatening condition where the lungs cannot provide enough oxygen to the body. Many patients are treated with non-invasive respiratory support (NRS) such as high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP). However, up to half of patients receiving NRS still deteriorate and require intubation and invasive ventilation, which is linked to longer hospital stays, more complications, and slower recovery. A major challenge in caring for these patients is that clinicians currently cannot directly see how well the breathing muscles (especially the diaphragm and parasternal intercostal muscles) and the lungs are working while the patient is using NRS. Existing bedside measures, such as respiratory rate or oxygen levels, only show part of the picture. They do not indicate how hard the patient is working to breathe or whether their respiratory muscles are becoming fatigued. This lack of information may delay important decisions about adjusting NRS settings or switching to other treatments. This study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care: 1. Ultrasound, which can measure breathing muscle thickness, movement, and lung aeration 2. Electrical impedance tomography (EIT), which uses a soft belt of small electrodes around the chest to measure changes in air and blood flow within different regions of the lungs in real time These tools have shown promise in earlier research, and interviews with patients and clinicians suggest they are comfortable, well-tolerated, and potentially useful. However, they have not yet been evaluated together in a real-world hospital environment where many acute respiratory failure patients are cared for outside the ICU. What the study will involve: Up to 100 adults with acute respiratory failure requiring any type of non invasive respiratory support will be recruited with the goal of obtaining complete data from at least 50 patients. Each participant will undergo ultrasound and EIT assessments up to seven times during the first 72 hours after starting NRS, plus an additional measurement if they improve enough to stop NRS or if they deteriorate and require intubation. These assessments take place at the bedside, require brief exposure of the upper chest, and last approximately 15-45 minutes. Routine clinical data-such as heart rate, oxygen levels, and breathing measures-will also be recorded. In parallel, clinical staff caring for these patients will complete a short Healthcare System Usability Scale questionnaire to rate how useful, understandable, and practical they find the information generated by ultrasound and EIT. Some staff may also take part in optional interviews to explore usability in more depth. What the study is trying to learn: The primary aim is to determine the usability of these monitoring methods meaning understanding if they are practical, easy to use, and helpful for clinicians making decisions about NRS treatment. Secondary aims include understanding: * how the respiratory muscles and lungs change over time during NRS * whether these changes are linked to treatment settings (e.g., flow rate, pressure support) * whether certain patterns are associated with treatment success or failure (intubation or death) * whether these tools could help identify patients at risk of deterioration earlier Risks and benefits: Both ultrasound and EIT are widely used, safe, and non-invasive. They involve no radiation, needles, or harmful exposure. Minor temporary discomfort from the gel or belt placement is possible. Participation will not change any clinical treatments. Although patients may not directly benefit, the study may help future patients by improving understanding of breathing muscle function and supporting more personalised respiratory care. By contributing to this research, patients and clinicians will help determine whether advanced monitoring can be realistically implemented in busy hospital settings and whether it could lay the groundwork for future trials aimed at improving outcomes for people with acute respiratory failure.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Queen Mary University of LondonUpdated: May 22, 2026Locations: 2
Eligibility criteria

Adult (≥18 years old) [+3]

Patients in respiratory arrest defined as the total cessation of airflow and bre... [+10]

Status: Recruiting

Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.

Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding. Aim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants. Methods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours. Outcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics. Statistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.

Participants needed: 45
Trial details
Biological sex: AllType: InterventionalSponsor: Rambam Health Care CampusUpdated: Nov 28, 2025Locations: 1
Eligibility criteria

Gestational age 240 to 336. [+4]

If flow is &lt;3 and tcCO2 related pCO2 is&lt;40mmHg. [+2]

Status: Recruiting

An International Survey on the Use of NIV Outside the ICU

Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs. While NIV has long been used in intensive care units, it is now increasingly applied in emergency rooms, hospital wards, and long-term care facilities. However, global data on how it is used outside ICUs-such as which patients receive it, how well it works, and what barriers exist-is lacking. The NIV-Safety Study is a worldwide survey of doctors, nurses, and respiratory therapists to understand current practices, outcomes, and challenges of NIV use beyond the ICU. The findings aim to guide safer, more effective, and standardized use of NIV across different healthcare settings.

Participants needed: 400
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Dr. Ram Manohar Lohia HospitalUpdated: Sep 30, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

Participants needed: 846
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: St. Joseph's Healthcare HamiltonUpdated: Sep 10, 2025Locations: 6
Eligibility criteria

Age ≥18 years [+5]

Absence of a functioning pacemaker with one of the following: a-Persistent brady... [+12]

Status: Recruiting

Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in the West of France

Home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. The aim of this treatment is to support alveolar hypoventilation. Concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. Prevalence of home children ventilation is in augmentation in France. The last national study in 2021 about infants show a prevalence of 9.3/100 000. Advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. Quality of life is a thematic less studying. Last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. This study were about few numbers of patients. The aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.

Participants needed: 160
Trial details
Age: 6-17Biological sex: AllType: InterventionalSponsor: University Hospital, AngersUpdated: Mar 19, 2025Locations: 1
Eligibility criteria

Child aged 6 months to 17 years treated with non-invasive ventilation at home fo... [+3]

Parents with poor command of the French language, implying not being able to com... [+1]

Status: Not yet recruiting

Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)

Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on the electrical activity of the muscles involved in breathing (neural respiratory drive), breathing mechanics (respiratory impedance measured by forced oscillation technique), respiratory flow, heart rate and rhythm, spirometry and breathlessness symptoms in patients with chronic obstructive pulmonary disease who require non-invasive ventilation.

Participants needed: 12
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Guy's and St Thomas' NHS Foundation TrustUpdated: Mar 19, 2025Locations: 1
Eligibility criteria

Patients with COPD receiving home non-invasive ventilation for chronic respirato... [+5]

Congestive cardiac failure [+8]

Status: Not yet recruiting

The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway

The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate: * How does soft palate anatomy change in different body positions? * What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate. Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics. Participants will be asked to: * Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions * Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner * Have their upper airway resistance measured, in different body positions

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fisher and Paykel HealthcareUpdated: Mar 5, 2025Locations: 1
Eligibility criteria

Healthy adults aged 18+ [+1]

Contraindications for MRI (such as metal implants) [+7]

Status: Recruiting

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation (HMV)

The goal of this clinical trial is to evaluate whether telemonitoring, added to the usual process of adaptation to home mechanical ventilation (HMV), achieves a more efficient correction of hypoventilation (reduction of hypercapnia).

Participants needed: 48
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUpdated: Mar 22, 2024Locations: 1
Eligibility criteria

Chronic hypercapnic respiratory failure with indication for home mechanical vent... [+2]

Patient already treated with mechanical ventilation or home CPAP. [+7]