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Prone Position in Patients on High-flow Nasal Oxygen Therapy for COVID-19 (HIGH-PRONE-COVID-19)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358939
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. Preliminary data from patients with ARDS related to COVID-19 disease appear to show significant effectiveness of prone positioning in intubated patients in terms of oxygenation as well as nasal high flow therapy before intubation. It should be noted that in Jiangsu province, secondarily affected, nasal high flow combined with the prone position was successfully integrated into care protocols.

The investigators hypothesize that the combined application of nasal high flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for tracheal intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.

Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome COVID-19 Other: Prone decubitus Not Applicable

Detailed Description:

Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. In patients with ARDS who are mechanically ventilated invasively through a tracheal tube and with a PaO2/FiO2 ratio (arterial oxygen partial pressure to inspired oxygen fraction ratio) of less than 150 mmHg, prone positioning significantly reduced mortality. Furthermore, nasal high flow, a non-invasive respiratory support and oxygenation technique, reduced the need for tracheal intubation and reduced mortality among the most severe patients (PaO2/FiO2 ratio less than 200 mmHg) suffering from acute hypoxemic respiratory failure. Prone positioning of ARDS patients treated with nasal high-flow was evaluated in 20 patients with predominantly viral pneumonia. The prone positioning was found to be feasible and associated with an increased PaO2/FiO2 ratio. Preliminary data from patients with ARDS related to COVID-19 disease appear to show a significant effect of prone positioning in intubated patients in terms of oxygenation improvement as well as nasal high-high flow appears effective in non-intubated patients. For instance, nearly half intensive care unit patients described in the princeps cohort in Wuhan City, Hubei Province, China, had received nasal high-flow. It should be noted that in Jiangsu province, secondarily affected, nasal high-flow combined with prone positioning was successfully integrated into care protocols.

Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : November 10, 2021
Estimated Study Completion Date : November 24, 2021


Arm Intervention/treatment
Experimental: Prone decubitus group
Prone positioning of patients on nasal high-flow oxygen therapy with usual care
Other: Prone decubitus
According to the tolerance, the objective is to spend as much time as possible, up to 16 hours and beyond in prone position every 24 hours. At least two sessions of at least 30 minutes each must be performed daily.

No Intervention: Control group
Patients on nasal high-flow oxygen therapy with usual care and positioned in supine



Primary Outcome Measures :
  1. Therapeutic failure within 14 days of randomization [ Time Frame: From randomization to day 14 ]
    Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels.


Secondary Outcome Measures :
  1. Therapeutic failure within 28 days of randomization [ Time Frame: From randomization to day 28 ]
    Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels.

  2. Timeframe of intubation or death [ Time Frame: From randomization to day 28 ]
  3. Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels) [ Time Frame: From randomization to day 28 ]
  4. Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization [ Time Frame: From randomization to day 14 ]
  5. Evolution of the SpO2/FiO2 ratio during the first prone session [ Time Frame: From randomization to day 1 ]
  6. Evolution of the ROX index during the first prone session [ Time Frame: From randomization to day 1 ]
    ROX index is the ratio of pulse oximetry (SpO2)/fraction of inspired oxygen (FiO2) to respiratory rate.

  7. Evolution of the World Health Organization disease severity score of COVID [ Time Frame: From randomization to day 28 ]
    Score reaches from 1 to 7, 7 indicates worse outcome

  8. Patient comfort before, during and after the first prone position session [ Time Frame: From randomization to day 1 ]
    Comfort evaluted by the patient through a visual analogical scale

  9. Occurrence of skin lesions on the anterior surface of the body [ Time Frame: From randomization to day 28 ]
  10. Displacement of invasive devices during reversals [ Time Frame: From randomization to day 28 ]
    Invasive devices include : central and peripheric vascular catheters, tracheal tube, urinary catheter, chest tubes.

  11. Days of nasal High-Flow therapy use in the general population, in non-intubated patients and in intubated patients [ Time Frame: From randomization to day 28 ]
  12. Days spent in the intensive care unit and in the hospital [ Time Frame: From randomization to day 28 ]
  13. Mortality in the intensive care unit and in the hospital [ Time Frame: From randomization to day 28 ]
  14. Ventilator-free-days within 28 days of randomization [ Time Frame: From randomization to day 28 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult patient
  • with COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very highly suspected.
  • Patient treated with nasal high-flow
  • Mild, moderate or severe ARDS: bilateral radiological opacities not fully explained by effusions, atelectasis or nodules; acute hypoxemia with worsening within the previous 7 days, not fully explained by left ventricular failure; PaO2/FiO2 ratio < 300 mmHg (or equivalent SpO2/FiO2).
  • Covered by or having the rights to French social security
  • Informed Consent

Exclusion Criteria:

Pregnant or breastfeeding woman

  • Indication for immediate tracheal intubation
  • Progressive significant acute circulatory insufficiency
  • Impaired alertness, confusion, restlessness
  • Body mass index > 40 kg/m2
  • Thoracic trauma or other contraindication to prone position
  • Pneumothorax with single anterior thoracic drain and persistent bubbling
  • Vulnerable person: safeguard of justice, guardianship or authorship known at inclusion

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): NCT04358939


Contacts
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Contact: Yonatan PEREZ, MD (0)2.47.47.98.51 ext +33 yonatperez@gmail.com
Contact: Stephan EHRMANN, MD-PhD (0)2.47.47.98.51 ext +33 stephan.ehrmann@univ-tours.fr

Locations
Show Show 28 study locations
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Yonatan PEREZ, MD No affiliation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT04358939    
Other Study ID Numbers: HIGH-PRONE-COVID-19
2020-A01121-38 ( Other Identifier: IdRCB )
DR200125 ( Other Identifier: University Hospital, Tours )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data after de-identification can be obtained by contacting the corresponding author.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available immediately following publication and ending in 5 years.
Access Criteria: Contact with the corresponding author.

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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 University Hospital, Tours:
Acute Respiratory Distress Syndrome
COVID-19
SARS-CoV-2
Nasal High-Flow
Prone position
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury