Clinical trial NCT05866289: Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure
Official title: Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival, Prosthesis
Oxygen Deficiency
Keywords: acute respiratory distress syndrome
COVID-19
conscious
prone position
survival rate
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 1069
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each awake 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.

Epidemiological, clinical, paraclinical, therapeutic and evolutionary data were collected using a data processing form including the different variables collected in the patients' medical records. These data were then computerized and analyzed using IBM SPSS version 21 software.

Qualitative variables were described as numbers and/or percentages, and quantitative variables as mean ± standard deviation, or as median with interquartile range for variables not having a normal distribution.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
timeFrame: 22 months
Secondary outcomes:
measure: length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
timeFrame: 22 months
Other outcomes:
Locations:
city: Oujda
country: Morocco
facility: Amine Elmouhib
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.