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Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure (PRO-CARF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477655
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Miguel Á Ibarra-Estrada, Hospital Civil de Guadalajara

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.

Condition or disease Intervention/treatment Phase
Covid19 Procedure: Awake prone positioning Procedure: Standard oxygen therapy Not Applicable

Detailed Description:
Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the treatment of moderate/severe disease is mainly supportive, including oxygen therapy and invasive mechanical ventilation when impending respiratory failure is established. Moreover, the associated mortality among mechanically intubated patients is overwhelmingly high. Prone position relieves the dependent lung regions from the compressive forces of the mediastinum's weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung regions. According to a few case series, and observational non-randomized studies with small sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during prone positioning, however there are no clinical evidence that this improvement is associated with a decrease in the risk of invasive mechanical ventilation. Considering that prone positioning is a low cost, low risk and widely available therapy, more high quality evidence is needed, to determine if the benefits of prone positioning in awake patients also include a lower requirement of mechanical ventilation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial
Actual Study Start Date : May 3, 2020
Actual Primary Completion Date : January 26, 2021
Actual Study Completion Date : January 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard oxygen therapy
Oxygen 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.
Procedure: Standard oxygen therapy
Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%

Experimental: Awake prone positioning
Oxygen 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%.
Procedure: Awake prone positioning
Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.




Primary Outcome Measures :
  1. Intubation rate [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Total hours of prone position at day [ Time Frame: 28 days ]
  2. Total number of prone sessions at day [ Time Frame: 28 days ]
  3. Hours of the longest prone session each day [ Time Frame: 28 days ]
  4. Change in oxygenation 1-hour after first prone session [ Time Frame: 1 hour ]
  5. Change in the ROX-index 1-hour after first prone session [ Time Frame: 1 hour ]
    The change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)

  6. Total days of prone positioning therapy [ Time Frame: 28 days ]
  7. Adverse effects of prone positioning therapy [ Time Frame: 28 days ]
  8. Mechanical ventilation days [ Time Frame: 28 days ]
  9. Intensive care unit length of stay [ Time Frame: 28 days ]
  10. Hospital length of stay [ Time Frame: 28 days ]
  11. Hospital mortality [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477655


Locations
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Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Hospital General de Occidente
Guadalajara, Jalisco, Mexico, 45170
Sponsors and Collaborators
Hospital Civil de Guadalajara
Investigators
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Principal Investigator: Miguel Ibarra-Estrada Investigator
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Miguel Á Ibarra-Estrada, Principal investigator, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT04477655    
Other Study ID Numbers: 048/20
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel Á Ibarra-Estrada, Hospital Civil de Guadalajara:
COVID-19
Severe
Prone positioning
High-flow nasal cannula
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases