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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each patient will be his own control. The order of the experimental periods will be:

1. arm A: prone position followed by dorsal decubitus
2. arm B: dorsal decubitus followed by ventral decubitus A 30-minute wash-out period is set between the end of sequence 1 and the start of sequence 2.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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patients in prone position followed by dorsal decubitus

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.

Group Type OTHER

physiological effects of awake prone position in COVID 19 patients

Intervention Type OTHER

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.

dorsal decubitus followed by prone decubitus

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.

Group Type OTHER

physiological effects of awake prone position in COVID 19 patients

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No