Respiratory FailureProneSpontCovNCT04632602
Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure
A study testing physiological effects of awake prone position in COVID 19 patients in people with Respiratory Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- physiological effects of awake prone position in COVID 19 patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study
Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.
Read the 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.
- Conditions
- Respiratory Failure
- Being tested
- physiological effects of awake prone position in COVID 19 patients
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiological effects of awake prone position in COVID 19 patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients in prone position followed by dorsal decubitus | Other | 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. Receives: Other: physiological effects of awake prone position in COVID 19 patients |
| dorsal decubitus followed by prone decubitus | Other | 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. Receives: Other: physiological effects of awake prone position in COVID 19 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.
Electrical Impedance Tomography (EIT)
Measured: 2hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start14 Apr 2020
- Primary completion29 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632602
- Sponsor's protocol ID
- 2020-17
- Acronym
- ProneSpontCov
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunelle T, Prud'homme E, Alphonsine JE, Baumstarck K, Sanz C, Salmi S, Peres N, Forel JM, Papazian L, Hraiech S, Roch A, Guervilly C. Awake prone position in COVID-19 acute respiratory failure: a randomised crossover study using electrical impedance tomography. ERJ Open Res. 2023 Mar 27;9(2):00509-2022. doi: 10.1183/23120541.00509-2022. eCollection 2023 Mar.
PubMed 36994452
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study
- ClinicalTrials.gov ID
- NCT04632602
- Acronym / sponsor ID
- ProneSpontCov / 2020-17
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients in prone position followed by dorsal decubitus | Other | Other: physiological effects of awake prone position in COVID 19 patientspatients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. |
| dorsal decubitus followed by prone decubitus | Other | Other: physiological effects of awake prone position in COVID 19 patientspatients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiological effects of awake prone position in COVID 19 patientsStudy 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. | Other | dorsal decubitus followed by prone decubitus, patients in prone position followed by dorsal decubitus |
Primary outcome
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.
Time frame: 2hours
Electrical Impedance Tomography (EIT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 36994452Brunelle T, Prud'homme E, Alphonsine JE, Baumstarck K, Sanz C, Salmi S, Peres N, Forel JM, Papazian L, Hraiech S, Roch A, Guervilly C. Awake prone position in COVID-19 acute respiratory failure: a randomised crossover study using electrical impedance tomography. ERJ Open Res. 2023 Mar 27;9(2):00509-2022. doi: 10.1183/23120541.00509-2022. eCollection 2023 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier ARNAUD study director
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiological effects of awake prone position in COVID 19 patients in people with Respiratory Failure, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods. (time frame: 2hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.