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

Covid19 Clinical Trial

— DeCOPO  

Official title:

Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543760
• Other study ID #: 2020-04-03
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 14, 2021

Study information

• Verified date: March 2022
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 14, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiratory Insufficiency

Intervention

Other:
• Prone position
prone positioning in spontaneous ventilation
• Supine position
supine positiong in spontaneous ventilation

Locations

Country	Name	City	State
France	Hopital Européen	Marseille
France	Hopital La Timone	Marseille
France	Hopital Nord	Marseille
France	Hopital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	?Peso measured using an esophageal balloon catheter	?Peso (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.	6 hours
Secondary	Concentration of CO2 at the end of expiration (EtCO2, mmHg)	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.	6 hours
Secondary	Intensity of dyspnea	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	6 hours
Secondary	Tolerance of the technique	measured by the visual analogue scale for pain (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 pain to 10 = worst pain possible	6 hours
Secondary	Tolerance of the technique	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	6 hours
Secondary	The occurrence of side effects due to PP	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.	6 hours