Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19

NCT04543760 | Completed

• 1 other identifier: 2020-04-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• [PaO2 / FiO2] ratio

  Oxygenation will be evaluated by the \[PaO2 / FiO2\] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.

  6 hours

Secondary Outcomes (6)

• ΔPeso measured using an esophageal balloon catheter

  6 hours

• Concentration of CO2 at the end of expiration (EtCO2, mmHg)

  6 hours

• Intensity of dyspnea

  6 hours

• Tolerance of the technique

  6 hours

• Tolerance of the technique

  6 hours

Study Arms (2)

[PP sequence 1] - Wash-out - [SP sequence 2]

OTHER

Other: Prone position; Other: Supine position

[SP sequence 1] - Wash-out - [PP sequence 2]

OTHER

Other: Prone position; Other: Supine position

Interventions

Prone position OTHER

prone positioning in spontaneous ventilation

[PP sequence 1] - Wash-out - [SP sequence 2]; [SP sequence 1] - Wash-out - [PP sequence 2]

Supine position OTHER

supine positiong in spontaneous ventilation

[PP sequence 1] - Wash-out - [SP sequence 2]; [SP sequence 1] - Wash-out - [PP sequence 2]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years,
• Admitted to ICU within 72 hours,
• Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
• Having acute hypoxemic respiratory failure with a \[PaO2/FiO2\] ratio between 100 mmHg and 300 mmHg,
• Having given free and informed written consent,
• Being affiliated with or benefiting from a social security scheme.

You may not qualify if:

• Unable to achieve a prone position for mobility reasons,
• Unable to achieve a prone position due to agitation whatever the cause,
• With clinical occlusive syndrome in order to limit the risk of inhalation,
• Having a contraindication to the use of the esophageal catheter,
• Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
• Having hypercapnia indicating the use of non-invasive ventilation (PaO2\> 50 mmHg),
• Having severe hypoxemia defined by PaO2 / FiO2 \<100mmHg,
• Ongoing pregnancy or breastfeeding,
• Subject to a measure for the protection of justice.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (4)

Hopital Européen

Marseille, 13003, France

Location

Hopital La Timone

Marseille, 13005, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Hopital Nord

Marseille, 13915, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position; Supine Position

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Samuel LEHINGUE, M.D

  Hopital Saint Joseph Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 10, 2020
• Study Start: October 1, 2020
• Primary Completion: January 15, 2021
• Study Completion: March 14, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 3 months and ending 2 years following article publication
• Access Criteria: The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. The proposal should be directed to the PI, Dr Lehingue.

Locations

FR (4)