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Noninvasive Technique and High Flow Nasal Oxygen in Respiratory Failure

ConditionRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinia University

About this trial

After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain management department Minia university hospital over a period from September 2025 to April 2026. This study is designed to compare the effectiveness of two protocols of sequential use of High Flow Nasal Cannula (HFNC) and noninvasive ventilation (NIV) versus NIV alone in patients with Acute Respiratory failure (ARF) admitted to the intensive care unit (ICU). The study will include 75 patients of both sexes, classified as ASA class Ⅰ-ⅠⅠⅠ, divided into three groups with 25 patients in each group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 year of both sexes. • Diagnosed with Acute Respiratory Failure (ARF) defined as the combination of a PaO2/FiO2 ratio < 300 after 15 minutes of conventional oxygen delivered through a face mask, with a FiO2 at least of 50% and respiratory rate > 30 breaths/min.

Disqualifiers

Chronic respiratory disease

Cardiogenic pulmonary edema

Life-threatening arrythmias

Hemodynamic instability requiring vasopressors

Trial design

Design model

Parallel

Treatments tested in this trial

  • HFNC

    Device

    High-flow nasal cannula (HFNC) is a valuable alternative for delivering oxygen therapy in patients with acute respiratory failure. It delivers heated and humidified oxygen at high flow rates-up to 60 L/min-through nasal prongs, allowing for better matching of inspiratory flow, a degree of positive airway pressure, and washout of nasopharyngeal dead space. These features contribute to improved oxygenation and reduced respiratory rate. Additionally, HFNC offers superior comfort and ease of communication compared to traditional masks, which may enhance patient compliance. Importantly, recent evidence suggests that HFNC can also assist in mild hypercapnic conditions by reducing the work of breathing and improving CO₂ clearance in selected patients

  • NIV

    Device

    Noninvasive ventilation (NIV) delivers positive airway pressure either continuously or in a bilevel mode to support ventilation and oxygenation. It has been widely used in managing conditions such as COPD exacerbations, cardiogenic pulmonary edema, and moderate forms of ARDS. NIV enhances alveolar ventilation, unloads respiratory muscles, and improves gas exchange while reducing the need for intubation in many cases. However, its effectiveness depends on proper patient selection and interface tolerance, and it may be less beneficial in patients with excessive secretions, altered mental status, or hemodynamic instability

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: HFNC and NIV 2:1Experimental treatment 2 interventions
Group B: HFNC and NIV 3:3Experimental treatment 2 interventions
Group C: NIV onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal)

The primary endpoint is the changes in PaO₂/FiO₂ ratio (the ratio of arterial oxygen partial pressure expressed in mmHg and the fraction of inspired oxygen expressed as a decimal) from baseline to 24 hours.

Time frame
From baseline and thoughout the first 24 hours of the start of the technique

Secondary outcomes

1

Changes in the arterial blood gases values: PH level, PaCO₂

Changes in the arterial blood gases values: PH level, PaCO₂ from baseline to 6, 12, 18 and 24h.

Time frame
From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
2

Respiratory rate

Respiratory rate

Time frame
At the baseline then at 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
3

Changes in the dyspnea score

Borg dyspnea score

Time frame
From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.
4

Patient-reported comfort scores

VAS (Visual Analogue Score)

Time frame
From baseline to 6th hour, 12th hour, 18th hour and 24th hour of the first day of the start of the technique.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Minia University Hospital

Collaborator

Source ClinicalTrials.gov
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