oxygen therapy in acute hypoxemic respiratory failure

Combined Low-Flow Nasal Cannula plus Non-Rebreathing Mask Versus High-Flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure: a Pragmatic Pilot Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605840498469

Enrollment

Registered

2026-05-28

Start date

2026-05-25

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

High Flow Nasal Cannula HFNC

LFNC and NRBM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (Age = 18 years). ? Diagnosis of acute hypoxemic respiratory failure, defined as: o PaO2/FiO2 ratio < 300 while breathing room air, or o SpO2 < 90% on room air requiring oxygen supplementation = 6 L/min to maintain SpO2 = 90%. ? Ability to provide informed consent (or from a legally authorized representative).

Exclusion criteria

Exclusion criteria: Hypercapnic respiratory failure (PaCO2 > 45 mmHg with pH < 7.35). ? Anatomical or surgical factors precluding a tight seal with the NRBM or proper placement of the nasal cannula (e.g., facial trauma, recent facial/oral surgery, significant nasal obstruction). ? Severely impaired consciousness (Glasgow Coma Scale = 12) or hemodynamic instability (requiring vasopressors at randomization). ? Do-not-intubate (DNI) status or patients receiving palliative care. ? Immediate need for intubation or non-invasive ventilation. ? Pregnancy.

Design outcomes

Primary

Measure	Time frame
escalation to higher-level respiratory support within 72 hours (defined as transition to HFNC, NIV, or IMV from LFNC+NRBM, and to NIV or IMV from HFNC)	—

Secondary

Measure	Time frame
Temporal changes in oxygenation parameters between groups, including PaO2 /FiO2 ratio, SpO2 /FiO2 ratio, respiratory rate, and (for HFNC patients) ROX index.To determine whether LFNC + NRBM achieves comparable short-term improvements in oxygenation (at 1, 6, 12, 24, 48, and 72 hours) to HFNC.;To assess patient comfort, tolerance, and symptom burden using a validated 0–10 visual analogue scale (VAS) and a structured tolerance checklist (dryness, heat, claustrophobia, noise, skin pressure). ? To compare the frequency of device intolerance or discontinuation due to discomfort between groups;To compare duration of oxygen therapy, ICU length of stay, and 28-day mortality between groups. To document and analyze crossover and rescue therapy events (including reasons and timing);To evaluate and categorize device-related adverse events (skin breakdown, nasal dryness, gastric distension, etc.) and clinical deterioration events (worsening hypoxemia, hemodynamic instability, or neurological compromise). To compare the incidence and severity of these events between groups;To assess recruitment, consent, and retention rates. To evaluate protocol adherence, completeness of data capture, and the practicality of blinding and data management procedures. To estimate event rates and variability required for the power calculation of a future definitive non-inferiority trial.	—

Measure

Time frame

Temporal changes in oxygenation parameters between groups, including PaO2 /FiO2 ratio, SpO2 /FiO2 ratio, respiratory rate, and (for HFNC patients) ROX index.To determine whether LFNC + NRBM achieves comparable short-term improvements in oxygenation (at 1, 6, 12, 24, 48, and 72 hours) to HFNC.;To assess patient comfort, tolerance, and symptom burden using a validated 0–10 visual analogue scale (VAS) and a structured tolerance checklist (dryness, heat, claustrophobia, noise, skin pressure). ? To compare the frequency of device intolerance or discontinuation due to discomfort between groups;To compare duration of oxygen therapy, ICU length of stay, and 28-day mortality between groups. To document and analyze crossover and rescue therapy events (including reasons and timing);To evaluate and categorize device-related adverse events (skin breakdown, nasal dryness, gastric distension, etc.) and clinical deterioration events (worsening hypoxemia, hemodynamic instability, or neurological compromise). To compare the incidence and severity of these events between groups;To assess recruitment, consent, and retention rates. To evaluate protocol adherence, completeness of data capture, and the practicality of blinding and data management procedures. To estimate event rates and variability required for the power calculation of a future definitive non-inferiority trial.

—

Countries

Egypt

Contacts

Public Contactkhaled gaballah

assistant professor of anesthesia and intensive care

khgaballah@gmail.com00201016009073

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026