Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure

Respiratory Failure Clinical Trial

— ProneSpontCov  

Official title:

Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632602
• Other study ID #: 2020-17
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

Description:

Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• more than 18 Years (Adult, Older Adult)

• Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)

• Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg

• Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen

• Written informed consent of the patient

Exclusion Criteria:

• Contra-indication to prone position including pregnancy

• Presence of pacemaker

• Severe hypoxemia with PaO2/FiO2 < 100 mmHg

• Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• physiological effects of awake prone position in COVID 19 patients
Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale). Measurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period.

Locations

Country	Name	City	State
France	Assistance Publique Höpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.	Electrical Impedance Tomography (EIT)	2hours