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Coronavirus InfectionProCovNCT04344106

Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study

A study testing Prone positioning in people with Coronavirus Infection and Oxygen Deficiency, run by ELHARRAR Xavier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infection, Oxygen Deficiency
What is being tested?
Prone positioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteFrance
Study dates
1 Apr 2020to 1 May 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

  • Patient aged at least 18 years;
  • Hospitalized in a COVID unit or intensive care unit;
  • Spontaneously breathing and with oxygen therapy with nasal canula, mask or High Flow Oxygen Therapy;
  • Requiring oxygen therapy ≥ 1l for Sat ≥ 90%;
  • COVID 19 positive in RT-PCR or diagnosis on clinicals symptoms and highly evocatives scannographics lesions in an epidemic period;
  • Chest scanner without injection within 72 hours prior to inclusion;
  • Bilateral scannographic lesions, including posterior condensations and/or posterior predominance of lesions;
  • Patient benefiting from French social security, under any regime

Who cannot join

  • acute respiratory distress (polypnea >25 or use of accessory respiratory muscles);
  • Alteration of consciousness;
  • Active or recent hemoptysis (<1 month);
  • Recent Thrombo-Embolic Venous Disease (< 1 month);
  • Pericardial effusion;
  • Pleural effusion of high abundance, clinical or scannographic;
Show all 12Show fewer
  • Chronic back or cervical pain/ history of spinal surgery/ bone metastases;
  • Wounds, facial trauma, tracheal, sternal or facial surgery < 15 days;
  • Recent abdominal surgery (< 1 month);
  • Intracranial HyperTension > 30mmHg;
  • Patient deprived of liberty, under guardianship or curatorship;
  • Pregnant or lactating woman.

Trial locations and contacts

1 site in 1 country.

Xavier ELHARRAR, MD contact

0442335650 ext. +33

rechercheclinique@ch-aix.fr

Youssef Trigui, MD contact

0033674215193

rechercheclinique@ch-aix.fr

France1 site, 1 recruiting

  • CHI Aix-Pertuis

    Aix-en-Provence, 13100

    Xavier ELHARRAR, 0442335650 ext. +33, rechercheclinique@ch-aix.fr

    Recruiting

Other trials in France

About this study

Official title: Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

Read the detailed description

SARS-CoV-2 is an RNA virus whose tropism for the respiratory system is responsible for many cases of acute respiratory failure. This can lead to acute respiratory distress syndrome (ARDS) requiring orotracheal intubation and mechanical ventilation. The prone position is a validated intensive care technique in the treatment of ARDS in mechanically ventilated patients. Performing prone position sessions improves patient oxygenation by optimizing the ventilation/perfusion ratios of the posterior areas of the lungs.

There is limited data in the literature on the ventral decubitus in spontaneous ventilation. They are mainly case series or retrospective studies. In the case of the SARS-CoV-2 epidemic, we are seeing patients with posterior lung involvement who may benefit from prone position sessions prior to mechanical ventilation. This maneuver, usually done in an intubated-ventilated-curarized patient, will be done in our spontaneous ventilation study in a conscious patient.The patient will then be placed in prone position with the help of physiotherapists so that the patient is correctly positioned.

The maneuver and the clinical monitoring of the patient's tolerance to the prone position will be done under medical and paramedical supervision, including monitoring of saturation during and after the procedure. A polygraph will also be installed on the patient in order to monitor the patient's position (on the back vs. on the stomach), saturation and heart rate during the entire prone position session. An arterial gasometry will be performed before the patient is placed in the prone position, one hour after and after returning to the supine position.

Being tested
Prone positioning
Medical subject headings
Coronavirus Infections, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prone positioningProcedure or surgery

    The prone positioning consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day.

Study groups in NCT04344106
Study groupRoleWhat they receive
Prone positioningExperimentalParticipants are all turned to prone position for an optimal minimum duration of 3 hours . Tolerance, oxygen saturation, heart rate and position are monitoring during all procedure. Arterial blood gases are realized before, 1 to 2 hours after the beginning of the prone position, and 6 to 12 hours after resupination.
Receives: Procedure: Prone positioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of "responder" patients to prone position

    PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

    Measured: 1 hour

Secondary outcomes (7)

  1. proportion of "persistent responders" patients after prone position

    PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.

    Measured: 1 day

  2. Evolution of PaO2

    PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.

    Measured: 1 day

  3. Duration of prone positioning and PaO2 evolution

    Look for an association between the time spent in Prone positione and persistent responder or not;

    Measured: 2 days

  4. Evolution of Spo2

    proportion of patients improving their arterial saturation within 1 hour of Prone Position

    Measured: 1 hour

  5. EVA Dyspnea

    evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position

    Measured: 1 day

  6. Intolerance to prone positioning

    proportion of patients intolerant to prone position (Prone Position <1h);

    Measured: 1 day

  7. Tolerance to prone positioning

    proportion of patients who can maintain prone position for more than 3 h.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start1 Apr 2020
  3. Primary completion15 Apr 2020 (estimated)
  4. Study completion1 May 2020 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04344106
Sponsor's protocol ID
20202703-2
Acronym
ProCov
Status last verified
Apr 2020
First submitted
8 Apr 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.

    PubMed 32189136

  • Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.

    PubMed 26271685

  • Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.

    PubMed 32000806

  • Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.

    PubMed 29068269

  • Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.

    PubMed 24134414

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PubMed 23688302

  • Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

    PubMed 32105637

Questions about this trial

What is this clinical trial studying?

A study testing Prone positioning in people with Coronavirus Infection and Oxygen Deficiency, run by ELHARRAR Xavier 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xavier ELHARRAR, MD (0442335650 ext. +33, rechercheclinique@ch-aix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of "responder" patients to prone position (time frame: 1 hour). 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 NCT04344106, which also lists 7 linked publications.

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 14 Apr 2020.

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