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Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients

NCT04715243 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2022-01-12

No results posted yet for this study

Summary

Objective: To determine whether NIV delivered through helmet interface reduces intubation rate among patients with COVID-19 ARDS compared to face-mask NIV and HFNC.

Design, setting \& participants: Two-center randomized clinical trial of 360 patients with mild to moderate ARDS and confirmed COVID-19 requiring non-invasive ventilation between August 2020 to January 2021. The patients with respiratory rate (RR) more than 30/min or oxygen saturation (SpO2) less than 90% or PaO2/FiO2 ratio less than 300 despite standard oxygen therapy by face mask (\<15 L/min) who present to Royal hospital or Sultan Qaboos University Hospital (SQUH) emergency department, medical wards or intensive care unit (ICU).

Intervention: Patients will be randomly assigned (block randomization) to either face-mask NIV, HFNC or Helmet NIV. The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal.

Main outcome and measures: The primary outcome is the rate of endotracheal intubation at 28-days. Secondary outcomes include hospital mortality at 28 and 90 days, NIV free days, invasive ventilator free days and hospital length of stay.

Expected results: We assume the failure rate of Helmet NIV to be 30%, failure rate of HFNC to be 40% and failure rate of face-mask NIV to be 50%. A sample size of 360 patients (120/group) will achieve a power of 0.90 at a significance level of 0.05. To account for 10% dropout rate, the total sample required is 396 subjects(132/group).

Conditions

  • Acute Respiratory Distress Syndrome Caused by COVID-19

Interventions

DEVICE

High flow nasal cannula (HFNC)

High flow nasal cannula as a form of non-invasive oxygen delivery

DEVICE

Helmet NIV

NIV interface

DEVICE

Face-mask NIV

NIV interface

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2021-08-09
Completion
2021-11-11

Countries

  • Oman

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 NCT04715243 on ClinicalTrials.gov