Helmet CPAP Versus HFNC in COVID-19

Not Applicable

Terminated

• Conditions: COVID; Acute Hypoxemic Respiratory Failure
• Interventions: Device: Helmet CPAP; Device: HFNC

• Registration Number: NCT04395807
• Lead Sponsor: Lund University

Brief Summary

We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.

Detailed Description

A detailed description can be found in the study protocol published in Trials in Dec 2020:

Tverring, J., Åkesson, A. \& Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Study Start: 2020-06-03
• Status Verified: 2021-04
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helmet CPAP	Helmet CPAP	Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).
HFNC	HFNC	High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)

Primary Outcome Measures

Name	Time	Method
Ventilator-Free Days (VFD)	28 days	Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.

Secondary Outcome Measures

Name	Time	Method
SpO2/FiO2-ratio	1 hour after randomisation	Peripheral oxygen saturation divided by fraction of inspired oxygen
Patient comfort	24 hours after randomisation	Visual scale (1-10)
Frequency of endotracheal intubation	28 days	Min 0, Max 1
Frequency of carbon dioxide rebreathing	28 days	Defined as pCO2 \> 6 kPa in a venous blood gas. Min 0, Max ∞
Days alive within	28 days and 180 days	All-cause mortality. (180 days endpoint not in primary publication)

Trial Locations

Locations (1)

Helsingborg's Hospital; 🇸🇪 Helsingborg, Region Skane, Sweden