Helmet Non-Invasive Ventilation for COVID-19 Patients

Conditions

Acute Hypoxemic Respiratory Failure, COVID-19

Keywords

helmet nonivasive ventilation

Brief summary

Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure

Detailed description

This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.

Marwa Amer, Hasan M. Al-Dorzi, Sara Aldekhyl, Saad Al Qahtani, K Lewis et al. (30 authors)

Scientific Reports2026-05-09

10.1038/s41598-026-49301-9

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19

Yaseen M. Arabi, Sara Aldekhyl, Saad Al Qahtani, Hasan M. Al‐Dorzi, Sheryl Ann Abdukahil et al. (80 authors)

JAMA2022-09-2062 citations

10.1001/jama.2022.15599

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial.

Arabi Y, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Jose J, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Alshahrani M, Albrahim T, Mady A, Al Bshabshe A, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Algethamy H, Alfaris O, Alnafel O, Al-Fares AA, Tlayjeh H.

2022-02-024 citations

10.1186/s13063-021-05988-x

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

Yaseen M. Arabi, Haytham Tlayjeh, Sara Aldekhyl, Hasan M. Al‐Dorzi, Sheryl Ann Abdukahil et al. (35 authors)

BMJ Open2021-08-017 citations

10.1136/bmjopen-2021-052169

Interventions

DEVICEHelmet non-invasive ventilation

Patients will be allocated to helmet non-invasive ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Suspected or confirmed COVID-19 * Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) * Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio \<200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate \>10 L/min or above * Intact airway protective gag reflex * Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)

Exclusion criteria

* Prior intubation during this hospital admission * Cardiopulmonary arrest * Glasgow coma scale \<12 * Tracheostomy * Upper airway obstruction * Active epistaxis * Requirement for more than one vasopressor to maintain mean arterial pressure \> 65 mm Hg * Pregnancy * Imminent intubation * Patients with do not intubate orders or equivalent * Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation * Patients already treated with helmet * Patients with chronic carbon dioxide retention (PaCO2 \>45) * Previous enrolment in this trial * The primary cause of respiratory failure is not heart failure as judged by the treating team

Design outcomes

Primary

Measure	Time frame	Description
28-day all-cause mortality	28 days from randomization	all cause mortality

Secondary

Measure	Time frame	Description
Intubation rate within 28 days	28 days from randomization	endotracheal intubation
ICU mortality	180 days from randomization	ICU death
Hospital mortality (censored at day 180)	180 days from randomization	hospital death
Hospital length of stay	180 days from randomization	length of stay in the hospital
ICU free days at day 28	28 days from randomization	days not in ICU
Invasive ventilation-free days at day 28	28 days from randomization	days without ventilator support
Renal replacement therapy-free days at day 28	28 days from randomization	days without renal replacement therapy received
Vasopressor-free days at day 28	28 days from randomization	days without vasopressor support
Safety outcome: skin pressure ulcers	28 days from randomization	presence of pressure ulcers
Safety outcome: barotrauma	28 days from randomization	incidence of barotrauma
Serious adverse events (including cardiovascular events and device complications)	28 days from randomization	reporting of abovementioned adverse events
180-day all-cause mortality	180 days from randomization	all cause mortality
Follow-up study: 180-day 5-level EQ-5D version	180 days from randomization	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Countries

Saudi Arabia

Outcome results

None listed