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

NCT04715243 | Terminated DMC

• 1 other identifier: SQU-EC/206/2020
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of endotracheal intubation

  The patient will be randomly assigned to one of the treatment arms. Then the patient will be followed up for one month for the primary outcome which is endotracheal intubation.

  within the study period with an average of one month.

Secondary Outcomes (3)

• Hospital mortality

  90 days from the hospital mortality.

• Hospital length of stay

  Throughout the study completion. An average of 90 days.

• Ventilator free days

  Throughout the study completion. An average of 90 days.

Study Arms (3)

control

OTHER

Face-mask NIV is the standard of care

Device: Face-mask NIV

intervention 1

ACTIVE COMPARATOR

High flow nasal cannula

Device: High flow nasal cannula (HFNC)

Intervention 2

ACTIVE COMPARATOR

Helmet NIV

Device: Helmet NIV

Interventions

High flow nasal cannula (HFNC) DEVICE

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

intervention 1

Helmet NIV DEVICE

NIV interface

Intervention 2

Face-mask NIV DEVICE

NIV interface

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• confirmed COVID-19
• Within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (ICU)
• ARDS according to Berlin definition (P/F \< 300) or O2 saturation \< 90% or RR \> 30/min) in room air
• Standard oxygen therapy at flow rate \< 15L/min x 60 minutes

You may not qualify if:

• More than 48 hours of admission to the emergency department, high dependency or intensive care unit
• More than 4 hours on NIV or HFNC before enrolment
• Impending cardiopulmonary arrest
• Need for immediate endotracheal intubation
• Hemodynamic instability or life-threatening arrhythmias
• GCS \< 8
• Active intracranial pathology or high ICP
• Inability to cooperate or protect the airway
• Pregnancy
• Tracheostomy
• DNR or refusing intubation
• Known type 2 respiratory failure
• On chronic home oxygen therapy

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related Publications (1)

• Al Hashim AH, Al Reesi A, Al Lawati NM, Burad J, Al Khabori M, Chandwani J, Al Lawati R, Al Masroori Y, Al Balushi AA, Al Masroori S, Al Siyabi K, Al Lawati F, Ahmed FYN, Al Busaidy M, Al Huraizi A, Al Jufaili M, Al Zaabi J, Varghese JT, Al Harthi R, Sebastian KP, Al Abri FH, Al Aghbari J, Al Mubaihsi S, Al Lawati A, Al Busaidi M, Foti G. Comparison of Noninvasive Mechanical Ventilation With High-Flow Nasal Cannula, Face-Mask, and Helmet in Hypoxemic Respiratory Failure in Patients With COVID-19: A Randomized Controlled Trial. Crit Care Med. 2023 Nov 1;51(11):1515-1526. doi: 10.1097/CCM.0000000000005963. Epub 2023 Jun 13.

  PMID: 37310174 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Multi-centre randomized trial of confirmed COVID-19 cases presenting to the emergency department, the ward, high dependency or intensive care unit (ICU) with ARDS requiring non-invasive mechanical ventilation. They will be assigned to one of the three arms; high flow nasal cannula (HFNC), Face-mask NIV or Helmet NIV.

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 20, 2021
• Study Start: February 2, 2021
• Primary Completion: August 9, 2021
• Study Completion: November 11, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after July 2021

Locations

OM (1)