Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

NCT ID: NCT05866289

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1069 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-30

Brief Summary

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The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

Detailed Description

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The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as limited ICU capacity is strained by a new high-mortality disease and large numbers of patients requiring prolonged periods of hospitalization, as well as respiratory support equipment such as ventilators and intensive care unit (ICU) beds.

If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV vigil) remains a subject of debate and research.

This is a retrospective, monocentric, descriptive and analytical cohort conducted over a period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute respiratory failure caused by COVID-19.

Conditions

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Survival, Prosthesis Oxygen Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Includes 681 patients who were placed in prone position

Prone position

Intervention Type OTHER

Each prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day.

Includes 388 patients who were placed in supine position

No interventions assigned to this group

Interventions

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Prone position

Each prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all patients (1069 patients) with ARDS due to SARS-cov2, confirmed by nasopharyngeal swab, who were hospitalized in the COVID-19 ICU from March 1, 2020 to December 31, 2021

Exclusion Criteria

* Patients with negative CRP
* Younger than 18 years of age
* Patients who died or intubated on the day of admission
* Patients presented a contraindication
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mohammed VI University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Younes Oujidi

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amine Elmouhib

Oujda, , Morocco

Site Status

Countries

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Morocco

References

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Winearls S, Swingwood EL, Hardaker CL, Smith AM, Easton FM, Millington KJ, Hall RS, Smith A, Curtis KJ. Early conscious prone positioning in patients with COVID-19 receiving continuous positive airway pressure: a retrospective analysis. BMJ Open Respir Res. 2020 Sep;7(1):e000711. doi: 10.1136/bmjresp-2020-000711.

Reference Type BACKGROUND
PMID: 32895247 (View on PubMed)

Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.

Reference Type BACKGROUND
PMID: 32455107 (View on PubMed)

Despres C, Brunin Y, Berthier F, Pili-Floury S, Besch G. Prone positioning combined with high-flow nasal or conventional oxygen therapy in severe Covid-19 patients. Crit Care. 2020 May 26;24(1):256. doi: 10.1186/s13054-020-03001-6. No abstract available.

Reference Type BACKGROUND
PMID: 32456663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32000806 (View on PubMed)

Retucci M, Aliberti S, Ceruti C, Santambrogio M, Tammaro S, Cuccarini F, Carai C, Grasselli G, Oneta AM, Saderi L, Sotgiu G, Privitera E, Blasi F. Prone and Lateral Positioning in Spontaneously Breathing Patients With COVID-19 Pneumonia Undergoing Noninvasive Helmet CPAP Treatment. Chest. 2020 Dec;158(6):2431-2435. doi: 10.1016/j.chest.2020.07.006. Epub 2020 Jul 15. No abstract available.

Reference Type BACKGROUND
PMID: 32679237 (View on PubMed)

Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.

Reference Type BACKGROUND
PMID: 32569585 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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unit critical care

Identifier Type: -

Identifier Source: org_study_id

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