Clinical trial NCT04477668: Helmet Non-Invasive Ventilation for COVID-19 Patients
Official title: Helmet Non-Invasive Ventilation for COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Acute Hypoxemic Respiratory Failure
Keywords: helmet nonivasive ventilation
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: King Abdulaziz Medical City, Riyadh, Saudi Arabia
name: King Fahd Hospital of the University, Al Khobar, Saudi Arabia
name: Aseer Central Hospital, Abha, Saudi Arabia
name: King Faisal Specialist Hospital & Research Center
name: King Fahad Hospital, Madinah, Saudi Arabia
name: Al Amiri Hospital, Kuwait
name: King Abdulaziz University Hospital, Jeddah, Saudi Arabia
name: King Saud Medical City
First posted: 2020-07-20
Enrollment: 322
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day all-cause mortality
timeFrame: 28 days from randomization
Secondary outcomes:
measure: Intubation rate within 28 days
timeFrame: 28 days from randomization
measure: ICU mortality
timeFrame: 180 days from randomization
measure: Hospital mortality (censored at day 180)
timeFrame: 180 days from randomization
measure: Hospital length of stay
timeFrame: 180 days from randomization
measure: ICU free days at day 28
timeFrame: 28 days from randomization
measure: Invasive ventilation-free days at day 28
timeFrame: 28 days from randomization
measure: Renal replacement therapy-free days at day 28
timeFrame: 28 days from randomization
measure: Vasopressor-free days at day 28
timeFrame: 28 days from randomization
measure: Safety outcome: skin pressure ulcers
timeFrame: 28 days from randomization
measure: Safety outcome: barotrauma
timeFrame: 28 days from randomization
measure: Serious adverse events (including cardiovascular events and device complications)
timeFrame: 28 days from randomization
measure: 180-day all-cause mortality
timeFrame: 180 days from randomization
measure: Follow-up study: 180-day 5-level EQ-5D version
timeFrame: 180 days from randomization
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Study officials:
affiliation: King Abdulaziz Medical City - Riyadh
name: Yaseen Arabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arabi YM, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Qasim E, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Aseri Z, Al-Omari A, Al-Dawood A, Tlayjeh H; Saudi Critical Care Trials Group. Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1063-1072. doi: 10.1001/jama.2022.15599.
citation: 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. Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial. Trials. 2022 Feb 2;23(1):105. doi: 10.1186/s13063-021-05988-x.
citation: Arabi YM, Tlayjeh H, Aldekhyl S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Al Qahtani S, Al-Hameed F, Chalabi J, Alshahrani M, Albrahim T, Alharthy A, Mady A, Bin Eshaq A, Al Bshabshe AA, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Al Ghamdi A, Altalag A, Alghamdi K, Almaani M, Algethamy H, Al Aqeily A, Al Baseet F, Al Samannoudi H, Al Obaidi M, Ismaiel YT, Al-Fares AA. Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Aug 26;11(8):e052169. doi: 10.1136/bmjopen-2021-052169.