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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Prone position; Other: Supine position

• Registration Number: NCT04543760
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-10
• Study Start: 2020-10-01
• Primary Completion: 2021-01-15
• Study Completion: 2021-03-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
[SP sequence 1] - Wash-out - [PP sequence 2]	Supine position	-
[PP sequence 1] - Wash-out - [SP sequence 2]	Supine position	-
[PP sequence 1] - Wash-out - [SP sequence 2]	Prone position	-
[SP sequence 1] - Wash-out - [PP sequence 2]	Prone position	-

Primary Outcome Measures

Name	Time	Method
[PaO2 / FiO2] ratio	6 hours	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.

Secondary Outcome Measures

Name	Time	Method
ΔPeso measured using an esophageal balloon catheter	6 hours	ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.
Tolerance of the technique	6 hours	measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible
Intensity of dyspnea	6 hours	assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible
Concentration of CO2 at the end of expiration (EtCO2, mmHg)	6 hours	Capnometry measurements by breathing on a mouthpiece connected to an online analyzer.; The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.
The occurrence of side effects due to PP	6 hours	Oxygen desaturation (SaO2 \<90%), occurrence of hemodynamic instability (Systolic blood pressure \<80 mmHg or heart rate \>120 mmHg for \>1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.

Trial Locations

Locations (4)

Hopital Saint Joseph; 🇫🇷 Marseille, France

Hopital La Timone; 🇫🇷 Marseille, France

Hopital Européen; 🇫🇷 Marseille, France

Hopital Nord; 🇫🇷 Marseille, France