Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure
PRO-CARF
1 other identifier
interventional
430
1 country
2
Brief Summary
Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started May 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2020
CompletedFirst Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2021
CompletedApril 13, 2021
April 1, 2021
9 months
July 15, 2020
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intubation rate
28 days
Secondary Outcomes (11)
Total hours of prone position at day
28 days
Total number of prone sessions at day
28 days
Hours of the longest prone session each day
28 days
Change in oxygenation 1-hour after first prone session
1 hour
Change in the ROX-index 1-hour after first prone session
1 hour
- +6 more secondary outcomes
Study Arms (2)
Standard oxygen therapy
ACTIVE COMPARATOROxygen therapy through high flow nasal cannula (HFNC). Continuous monitoring of vital signs. Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%. Prone positioning will be allowed as a rescue therapy.
Awake prone positioning
EXPERIMENTALOxygen therapy through high flow nasal cannula (HFNC). Patients will be asked to remain in prone position throughout the day as long as possible, with breaks according to tolerance. Pillows will be offered for maximizing comfort at chest, pelvis and knees. Monitoring of vital signs will not be suspended. Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%.
Interventions
Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.
Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%
Eligibility Criteria
You may qualify if:
- Adult patients with confirmed COVID-19, and requirement of a fraction of inspired oxygen (FiO2) ≥30% through high-flow nasal cannula (HFNC) to maintain a capillary saturation of ≥90%
You may not qualify if:
- Less than 18 years-old
- Pregnancy
- Patients with immediate need of invasive mechanical ventilation
- Contraindications for prone positioning therapy
- Do-not-resuscitate or do-not-intubate order
- Refusal of the patient or decision maker to enroll in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Hospital General de Occidente
Guadalajara, Jalisco, 45170, Mexico
Related Publications (3)
Ibarra-Estrada M, Li J, Pavlov I, Perez Y, Roca O, Tavernier E, McNicholas B, Vines D, Marin-Rosales M, Vargas-Obieta A, Garcia-Salcido R, Aguirre-Diaz SA, Lopez-Pulgarin JA, Chavez-Pena Q, Mijangos-Mendez JC, Aguirre-Avalos G, Ehrmann S, Laffey JG. Factors for success of awake prone positioning in patients with COVID-19-induced acute hypoxemic respiratory failure: analysis of a randomized controlled trial. Crit Care. 2022 Mar 28;26(1):84. doi: 10.1186/s13054-022-03950-0.
PMID: 35346319DERIVEDEhrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
PMID: 34425070DERIVEDIbarra-Estrada MA, Marin-Rosales M, Garcia-Salcido R, Aguirre-Diaz SA, Vargas-Obieta A, Chavez-Pena Q, Lopez-Pulgarin JA, Mijangos-Mendez JC, Aguirre-Avalos G. Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 23;21(1):940. doi: 10.1186/s13063-020-04882-2.
PMID: 33225990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Ibarra-Estrada
Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 15, 2020
First Posted
July 20, 2020
Study Start
May 3, 2020
Primary Completion
January 26, 2021
Study Completion
January 26, 2021
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share