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Status unknownNCT05327205CA_C_PROUpdated Apr 27, 2023

Chest and Abdominal Compression Versus PROne Position

An observational study in COVID-19 Acute Respiratory Distress Syndrome, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study summary

Acute respiratory distress syndrome (ARDS) is a severe pulmonary insult responsible for major, life-threatening hypoxemia. The alteration of hematosis is secondary to alveolar edema, following damage to the alveolocapillary barrier in response to a systemic inflammatory process. The presence of fluid effusion within the alveolar sacs and the modification of type II pneumocyte activity due to the presence of numerous pro-inflammatory mediators will lead to a quantitative and qualitative alteration of the surfactant. At the same time, leukocyte infiltration will lead to an alteration of the support tissue and to the accumulation of cellular debris. All these elements will lead to a heterogeneous loss of aeration of the lung. In addition, the alveolar units are compressed by the entire lung parenchyma due to the effect of gravity on the edematous tissue.

The treatment of ARDS is based on the antagonistic need to maintain hematosis and reduce parenchymal insult secondary to mechanical ventilation. Optimization of mechanical ventilation consists in reducing the volume of gas administered at each respiratory cycle and in limiting thoracic parietal stress by the use of curares. More recently, the interest of the ventral decubitus position has been demonstrated. During such a maneuver, the posterior pulmonary parenchymatous zones, usually subjected to gravity in the supine position, will be able to re-expand under the effect of the prone position and of the positive pressure induced by the ventilator. The increase in parietal elastance, due to the compression of the thorax between the posterior part of the trunk and the bed, also contributes to an improvement in the distribution of inhaled gases within the pulmonary parenchyma by limiting the loss of energy, transmitted directly to the wall. The ventral decubitus position allows to redistribute the ventilation in territories which were not aired before but which participate to the respiratory exchanges because they are still perfused and thus to improve the pulmonary compliance measured.

Although described as an atypical form, SARS-CoV-2 infection can lead to ARDS with severe forms of viral pneumonia and thus require prone positioning.

While this results in improved oxygenation and compliance, prone positioning is accompanied by a risk of complications such as pressure sores, described as the most frequent. In addition, the massive influx of patients and more generally the lack of personnel during pandemic peaks has made the application of prone position sometimes complex because it requires human resources. As a result, the benefit/risk ratio of the maneuver is difficult to determine because not all patients respond in the same way to prone positioning. It appeared essential to be able to predict the expected benefit of the prone position before performing the procubitus maneuver.

The application of thoracic and abdominal pressures, as part of the respiratory management of patients, is a technique commonly used by physiotherapists. Investigators have demonstrated a similar change in measured lung parenchymal compliance during manual compression of a patient's chest and during prone positioning. In the context of the epidemic, investigators used this test systematically to determine which patients were most likely to benefit from prone positioning and for whom the available resources should be concentrated at any given time.

02

Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 8 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients were admitted to the ICU for acute respiratory distress syndrome at COVID-19 between 04/10/2021 and 04/01/2022.

Inclusion criteria

  • Patient whose age ≥ 18 years
  • Patient hospitalized in the ICU for acute respiratory distress syndrome at Covid-19
  • Ventilated intubated patient for whom prone sessions were offered
  • Patient who received respiratory physical therapy sessions on the same day as the prone position
  • French-speaking patient

Exclusion criteria

Exclusion Criteria:

  • Non-intubated patient performing vigorous prone sessions
  • Patient on invasive mechanical ventilation for another etiology than Covid-19
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Effect of thoracic compression on motor pressure

    This outcome corresponds to the motor pressure measured during inspiration (in cmH2O) under two specific conditions: during manual pressure and during prone position.

    Time frame: Day 1

Secondary outcomes

  1. Response to thoracic and/or abdominal pressure and prone position on resistive pressure

    This outcome corresponds to the resistive pressure measured at inspiration (in cmH2O) during manual pressure and during prone position.

    Time frame: Day 1

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint-Joseph
    Paris, 75014, France
08

References and documents

Publications

  • 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 ↗
  • Villar J. What is the acute respiratory distress syndrome? Respir Care. 2011 Oct;56(10):1539-45. doi: 10.4187/respcare.01395. PubMed 22008395 ↗
  • Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907. PubMed 29466596 ↗
  • 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 ↗
  • Tirolien JA, Garnier M. [COVID-19, an atypical acute respiratory distress syndrome]. Prat Anesth Reanim. 2020 Sep;24(4):225-229. doi: 10.1016/j.pratan.2020.07.001. Epub 2020 Jul 10. French. PubMed 32837209 ↗
  • Borges LF, Saraiva MS, Saraiva MAS, Macagnan FE, Kessler A. Expiratory rib cage compression in mechanically ventilated adults: systematic review with meta-analysis. Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):96-104. doi: 10.5935/0103-507X.20170014. PubMed 28444078 ↗
  • Sweeney RM, McAuley DF. Acute respiratory distress syndrome. Lancet. 2016 Nov 12;388(10058):2416-2430. doi: 10.1016/S0140-6736(16)00578-X. Epub 2016 Apr 28. Erratum In: Lancet. 2016 Nov 12;388(10058):2354. doi: 10.1016/S0140-6736(16)32136-5. PubMed 27133972 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05327205
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Apr 8, 2022
Primary completion
May 8, 2022
Completion
Dec 31, 2023 (estimated)
Last update
Apr 27, 2023

Study contacts

Christophe Romanet
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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