Back to resultsHelmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID)
Primary Purpose
COVID-19, Acute Hypoxemic Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Helmet non-invasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring helmet nonivasive ventilation
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
Sites / Locations
- Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Helmet group
Control group
Arm Description
Patients will be allocated to helmet non-invasive ventilation
Patients will be allocated to standard of care
Outcomes
Primary Outcome Measures
28-day all-cause mortality
all cause mortality
Secondary Outcome Measures
Intubation rate within 28 days
endotracheal intubation
ICU mortality
ICU death
Hospital mortality (censored at day 180)
hospital death
Hospital length of stay
length of stay in the hospital
ICU free days at day 28
days not in ICU
Invasive ventilation-free days at day 28
days without ventilator support
Renal replacement therapy-free days at day 28
days without renal replacement therapy received
Vasopressor-free days at day 28
days without vasopressor support
Safety outcome: skin pressure ulcers
presence of pressure ulcers
Safety outcome: barotrauma
incidence of barotrauma
Serious adverse events (including cardiovascular events and device complications)
reporting of abovementioned adverse events
180-day all-cause mortality
all cause mortality
Follow-up study: 180-day 5-level EQ-5D version
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.
Full Information
NCT ID
NCT04477668
First Posted
July 9, 2020
Last Updated
September 6, 2022
Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz Medical City, Riyadh, Saudi Arabia, King Fahd Hospital of the University, Al Khobar, Saudi Arabia, Aseer Central Hospital, Abha, Saudi Arabia, King Faisal Specialist Hospital & Research Center, King Fahad Hospital, Madinah, Saudi Arabia, Al Amiri Hospital, Kuwait, King Abdulaziz University Hospital, Jeddah, Saudi Arabia, King Saud Medical City, Riyadh, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT04477668
Brief Title
Helmet Non-Invasive Ventilation for COVID-19 Patients
Acronym
Helmet-COVID
Official Title
Helmet Non-Invasive Ventilation for COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
Collaborators
King Abdulaziz Medical City, Riyadh, Saudi Arabia, King Fahd Hospital of the University, Al Khobar, Saudi Arabia, Aseer Central Hospital, Abha, Saudi Arabia, King Faisal Specialist Hospital & Research Center, King Fahad Hospital, Madinah, Saudi Arabia, Al Amiri Hospital, Kuwait, King Abdulaziz University Hospital, Jeddah, Saudi Arabia, King Saud Medical City, Riyadh, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Acute Hypoxemic Respiratory Failure
Keywords
helmet nonivasive ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helmet group
Arm Type
Experimental
Arm Description
Patients will be allocated to helmet non-invasive ventilation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will be allocated to standard of care
Intervention Type
Device
Intervention Name(s)
Helmet non-invasive ventilation
Intervention Description
Patients will be allocated to helmet non-invasive ventilation
Primary Outcome Measure Information:
Title
28-day all-cause mortality
Description
all cause mortality
Time Frame
28 days from randomization
Secondary Outcome Measure Information:
Title
Intubation rate within 28 days
Description
endotracheal intubation
Time Frame
28 days from randomization
Title
ICU mortality
Description
ICU death
Time Frame
180 days from randomization
Title
Hospital mortality (censored at day 180)
Description
hospital death
Time Frame
180 days from randomization
Title
Hospital length of stay
Description
length of stay in the hospital
Time Frame
180 days from randomization
Title
ICU free days at day 28
Description
days not in ICU
Time Frame
28 days from randomization
Title
Invasive ventilation-free days at day 28
Description
days without ventilator support
Time Frame
28 days from randomization
Title
Renal replacement therapy-free days at day 28
Description
days without renal replacement therapy received
Time Frame
28 days from randomization
Title
Vasopressor-free days at day 28
Description
days without vasopressor support
Time Frame
28 days from randomization
Title
Safety outcome: skin pressure ulcers
Description
presence of pressure ulcers
Time Frame
28 days from randomization
Title
Safety outcome: barotrauma
Description
incidence of barotrauma
Time Frame
28 days from randomization
Title
Serious adverse events (including cardiovascular events and device complications)
Description
reporting of abovementioned adverse events
Time Frame
28 days from randomization
Title
180-day all-cause mortality
Description
all cause mortality
Time Frame
180 days from randomization
Title
Follow-up study: 180-day 5-level EQ-5D version
Description
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.
Time Frame
180 days from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaseen Arabi, MD
Organizational Affiliation
King Abdulaziz Medical City - Riyadh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36125473
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.
Results Reference
derived
PubMed Identifier
35109898
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.
Results Reference
derived
PubMed Identifier
34446500
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.
Results Reference
derived
Learn more about this trial
Helmet Non-Invasive Ventilation for COVID-19 Patients
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