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

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT04358939

Collaborator

(none)

405

Enrollment

Locations

Arms

9.9

Actual Duration (Months)

16.9

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

405 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 :

Apr 27, 2020

Actual Primary Completion Date :

Feb 21, 2021

Actual Study Completion Date :

Feb 21, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Therapeutic failure within 14 days of randomization [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

Therapeutic failure within 28 days of randomization [From randomization to day 28]
Therapeutic failure is defined by death or intubation or use of non-invasive ventilation at two pressure levels.
Timeframe of intubation or death [From randomization to day 28]
Timeframe of therapeutic escalation (in case of non-invasive ventilation at two pressure levels) [From randomization to day 28]
Evolution of oxygenation (PaO2/FiO2 ratio or SpO2/FiO2 surrogate) over the 14 days following randomization [From randomization to day 14]
Evolution of the SpO2/FiO2 ratio during the first prone session [From randomization to day 1]
Evolution of the ROX index during the first prone session [From randomization to day 1]
ROX index is the ratio of pulse oximetry (SpO2)/fraction of inspired oxygen (FiO2) to respiratory rate.
Evolution of the World Health Organization disease severity score of COVID [From randomization to day 28]
Score reaches from 1 to 7, 7 indicates worse outcome
Patient comfort before, during and after the first prone position session [From randomization to day 1]
Comfort evaluted by the patient through a visual analogical scale
Occurrence of skin lesions on the anterior surface of the body [From randomization to day 28]
Displacement of invasive devices during reversals [From randomization to day 28]
Invasive devices include : central and peripheric vascular catheters, tracheal tube, urinary catheter, chest tubes.
Days of nasal High-Flow therapy use in the general population, in non-intubated patients and in intubated patients [From randomization to day 28]
Days spent in the intensive care unit and in the hospital [From randomization to day 28]
Mortality in the intensive care unit and in the hospital [From randomization to day 28]
Ventilator-free-days within 28 days of randomization [From randomization to day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Intensive Care Unit, University Hospital, Aix	Aix-en-Provence	France	13616
2	Medical Intensive Care Unit, University Hospital, Amiens	Amiens	France	80054
3	Intensive Care Unit, Hospital, Argenteuil	Argenteuil	France	95100
4	Intensive Care Unit, Hospital,	Blois	France	41016
5	Medical Intensive Care Unit, University Hospital, Brest	Brest	France	29609
6	Medical Intensive Care Unit, Hospital, Béthune	Béthune	France	62408
7	Medical Intensive Care Unit, University Hospital, Caen	Caen	France	14033
8	Intensive Care Unit, Louis Mourier-APHP	Colombes	France	92700
9	Intensive Care Unit, Hospital, Dax	Dax	France	40107
10	Medical Intensive Care Unit, University Hospital, Dijon	Dijon	France	21033
11	Medical Intensive Care Unit, University Hospital, Grenoble	Grenoble	France
12	Intensive Care Unit, Hospital, La Roche-sur-Yon	La Roche-sur-Yon	France	85925
13	Intensive Care Unit, Hospital, Le Mans	Le Mans	France	72037
14	Intensive Care Unit, University Hospital, Lille	Lille	France	59037
15	Medical Intensive Care Unit, University Hospital, Nantes	Nantes	France	44093
16	Medical Intensive Care Unit, University Hospital, Nice	NIce	France	06202
17	Medical Intensive Care Unit, Hospital, Orléans	Orléans	France	45067
18	Medical Intensive Care Unit, Tenon-APHP	Paris	France	75020
19	Medical Intensive Care Unit, University Hospital, Poitiers	Poitiers	France	86021
20	Medical Intensive Care Unit, University Hospital, Tours	Tours	France	37044
21	Surgical Intensive Care Unit, University Hospital, Tours	Tours	France	37170
22	Intensive Care Unit, Hospital, Valence	Valence	France	26953
23	Medical Intensive Care Unit, University Hospital, Nancy	Vandœuvre-lès-Nancy	France	54511
24	Intensive Care Unit, Hospital, Vannes	Vannes	France	56017