Awake Prone Positioning in COVID-19 Suspects With Hypoxemic Respiratory Failure
1 other identifier
interventional
61
1 country
1
Brief Summary
The investigator hypothesis is that early implementation of early, awake prone position for patients with COVID-19 pneumonia requiring oxygen therapy will reduce the need for escalation of respiratory support. Escalation of respiratory support is defined as the need for respiratory support with HFNO, NIV or IV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedStudy Start
First participant enrolled
May 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2021
CompletedAugust 4, 2022
August 1, 2022
2 months
April 12, 2021
August 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients requiring escalation to NIV (CPAP or BIPAP) or IV in each group
To assess the potential for prone position to reduce the requirement for escalation of respiratory support.
30 days
Study Arms (2)
PRONE
EXPERIMENTALAny combination of prone or side position for 3 hours, 3 times a day for 3 days.
NO PRONE
ACTIVE COMPARATORUsual care
Interventions
Any combination of prone or side position for 3 hours, 3 times a day for 3 days
Eligibility Criteria
You may qualify if:
- SPO2 less than 94% or Oxygen requirment of more than 5 liters.
- Requiring oxygen therapy in Hospital\< 24 hours
You may not qualify if:
- Clinical assessment for immediate intervention.
- PF\<50
- SF\<90
- RR\>60bpm
- Hemodynamics instability with need for vasopressors.
- MSOF
- Age\<18
- Pregnancy
- Impaired LOC, agitation or lack of cooperative patient.
- BMI\>40
- Unstable spine or pelvis
- Abdominal wound
- Pnemothorax
- Any injury or illness that may be worsened or result in pain as a result of prone position.
- DNAR
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamad Medical Corporation
Doha, 3050, Qatar
Related Publications (1)
Harris TRE, Bhutta ZA, Qureshi I, Kharma N, Raza T, Hssain AA, Pathare AS, D'Silva A, Khatib MY, Mohamedali MGH, Macineira IMG, Garcia Hernandez VR, Garcia JR, Thomas SH, Pathan SA. A randomised clinical trial of awake prone positioning in COVID-19 suspects with acute hypoxemic respiratory failure. Contemp Clin Trials Commun. 2024 Apr 13;39:101295. doi: 10.1016/j.conctc.2024.101295. eCollection 2024 Jun.
PMID: 38689829DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Prone position cannot be masked to any member in the trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice chairman Education Emergency Department
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 22, 2021
Study Start
May 16, 2021
Primary Completion
July 12, 2021
Study Completion
July 12, 2021
Last Updated
August 4, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share