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Completed

NCT Number: NCT04632602

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

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

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Höpitaux de Marseille

Marseille, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiological effects of awake prone position in COVID 19 patients

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.

Primary outcomes

  1. Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.

    Time frame: 2hours

    Electrical Impedance Tomography (EIT)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: ProneSpontCov

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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