Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET).
Trials
; 21(1): 994, 2020 Dec 03.
Article
in English
| MEDLINE | ID: covidwho-958043
ABSTRACT
BACKGROUND:
Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking.METHODS:
We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 11 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021.DISCUSSION:
We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic. TRIAL REGISTRATION ClinicalTrials.gov NCT04395807 . Registered on 20 May 2020.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Continuous Positive Airway Pressure
/
Cannula
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adult
/
Female
/
Humans
/
Male
Country/Region as subject:
Europa
Language:
English
Journal:
Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2020
Document Type:
Article
Affiliation country:
S13063-020-04863-5
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