Helmet Non-Invasive Ventilation for COVID-19 Patients

COVID-19 Clinical Trial

— Helmet-COVID  

Official title:

Helmet Non-Invasive Ventilation for COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477668
• Other study ID #: RC20/306/R
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: June 30, 2022
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• COVID-19
• Respiratory Insufficiency

Intervention

Device:
• Helmet non-invasive ventilation
Patients will be allocated to helmet non-invasive ventilation

Locations

Country	Name	City	State
Saudi Arabia	Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs	Riyadh

Sponsors (9)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	Al Amiri Hospital, Kuwait, Aseer Central Hospital, Abha, Saudi Arabia, King Abdulaziz Medical City, Riyadh, Saudi Arabia, King Abdulaziz University Hospital, Jeddah, Saudi Arabia, King Fahad Hospital, Madinah, Saudi Arabia, King Fahd Hospital of the University, Al Khobar, Saudi Arabia, King Faisal Specialist Hospital & Research Center, King Saud Medical City, Riyadh, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day all-cause mortality	all cause mortality	28 days from randomization
Secondary	Intubation rate within 28 days	endotracheal intubation	28 days from randomization
Secondary	ICU mortality	ICU death	180 days from randomization
Secondary	Hospital mortality (censored at day 180)	hospital death	180 days from randomization
Secondary	Hospital length of stay	length of stay in the hospital	180 days from randomization
Secondary	ICU free days at day 28	days not in ICU	28 days from randomization
Secondary	Invasive ventilation-free days at day 28	days without ventilator support	28 days from randomization
Secondary	Renal replacement therapy-free days at day 28	days without renal replacement therapy received	28 days from randomization
Secondary	Vasopressor-free days at day 28	days without vasopressor support	28 days from randomization
Secondary	Safety outcome: skin pressure ulcers	presence of pressure ulcers	28 days from randomization
Secondary	Safety outcome: barotrauma	incidence of barotrauma	28 days from randomization
Secondary	Serious adverse events (including cardiovascular events and device complications)	reporting of abovementioned adverse events	28 days from randomization
Secondary	180-day all-cause mortality	all cause mortality	180 days from randomization
Secondary	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.	180 days from randomization