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HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

NCT05078034 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-16

No results posted yet for this study

Summary

This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).

Conditions

  • Acute Hypoxemic Respiratory Failure

Interventions

DEVICE

Helmet Non-Invasive Ventilation (HNIV)

HNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated.

DEVICE

High Flow Nasal Oxygen

HFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Damon Scales, MD PhD FRCPC · Sunnybrook Health Sciences Centre

  • Niall Fergusson, MD FRCPC · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2026-03-31
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078034 on ClinicalTrials.gov