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

COVID-19 Clinical Trial

Official title:

Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358939
• Other study ID #: HIGH-PRONE-COVID-19
• Secondary ID: 2020-A01121-38DR
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: February 21, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: February 21, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Intensive Care Unit, University Hospital, Aix	Aix-en-Provence
France	Medical Intensive Care Unit, University Hospital, Amiens	Amiens
France	Intensive Care Unit, Hospital, Argenteuil	Argenteuil
France	Medical Intensive Care Unit, Hospital, Béthune	Béthune
France	Intensive Care Unit, Hospital,	Blois
France	Medical Intensive Care Unit, University Hospital, Brest	Brest
France	Medical Intensive Care Unit, University Hospital, Caen	Caen
France	Intensive Care Unit, Louis Mourier-APHP	Colombes
France	Intensive Care Unit, Hospital, Dax	Dax
France	Medical Intensive Care Unit, University Hospital, Dijon	Dijon
France	Medical Intensive Care Unit, University Hospital, Grenoble	Grenoble
France	Intensive Care Unit, Hospital, La Roche-sur-Yon	La Roche-sur-Yon
France	Intensive Care Unit, Hospital, Le Mans	Le Mans
France	Intensive Care Unit, University Hospital, Lille	Lille
France	Medical Intensive Care Unit, University Hospital, Nantes	Nantes
France	Medical Intensive Care Unit, University Hospital, Nice	NIce
France	Medical Intensive Care Unit, Hospital, Orléans	Orléans
France	Medical Intensive Care Unit, Tenon-APHP	Paris
France	Medical Intensive Care Unit, University Hospital, Poitiers	Poitiers
France	Medical Intensive Care Unit, University Hospital, Tours	Tours
France	Surgical Intensive Care Unit, University Hospital, Tours	Tours
France	Intensive Care Unit, Hospital, Valence	Valence
France	Medical Intensive Care Unit, University Hospital, Nancy	Vandœuvre-lès-Nancy
France	Intensive Care Unit, Hospital, Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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