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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT04715243
• Date of registration: 09/01/2021
• Prospective Registration: Yes
• Primary sponsor: Sultan Qaboos University
• Public title: Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients NIV COVID19
• Scientific title: Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients
• Date of first enrolment: February 2, 2021
• Target sample size: 360
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04715243
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Oman

Contacts

• Name: Abdul Hakeem Al Hashim, MD, FRCPC

• Name: Abdul Hakeem Al Hashim, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- > 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome Caused by COVID-19

Intervention(s)

Device: Face-mask NIV

Device: Helmet NIV

Device: High flow nasal cannula (HFNC)

Primary Outcome(s)

Rate of endotracheal intubation [Time Frame: within the study period with an average of one month.]

Secondary Outcome(s)

Hospital length of stay [Time Frame: Throughout the study completion. An average of 90 days.]

Hospital mortality [Time Frame: 90 days from the hospital mortality.]

Ventilator free days [Time Frame: Throughout the study completion. An average of 90 days.]

Secondary ID(s)

SQU-EC/206/2020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors