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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04632602
Acronym
ProneSpontCov
Enrollment
20
Registered
2020-11-17
Start date
2020-04-14
Completion date
2020-12-31
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief summary

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

Detailed 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.

Interventions

OTHERphysiological 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.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.2hoursElectrical Impedance Tomography (EIT)

Countries

France

Contacts

STUDY_DIRECTORJean-Olivier ARNAUD

ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026