Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

NCT05866289 | Completed

• 1 other identifier: unit critical care
• Study Type: observational
• Target: 1,069
• Locations: 1 country
• Sites: 1

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.

Conditions

Survival, Prosthesis; Oxygen Deficiency

Keywords

acute respiratory distress syndrome; COVID-19; conscious; prone position; survival rate

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

  Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

  22 months

Secondary Outcomes (1)

• length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.

  22 months

Study Arms (2)

Includes 681 patients who were placed in prone position

Other: Prone position

Includes 388 patients who were placed in supine position

Interventions

Prone position 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 681 patients who were placed in prone position

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mohammed VI University Hospital: lead

Study Sites (1)

Amine Elmouhib

Oujda, 60000, Morocco

Location

Related Publications (6)

• 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.

  PMID: 32895247 BACKGROUND

• 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.

  PMID: 32455107 BACKGROUND

• 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.

  PMID: 32456663 BACKGROUND

• 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.

  PMID: 32000806 BACKGROUND

• 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.

  PMID: 32679237 BACKGROUND

• 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.

  PMID: 32569585 BACKGROUND

MeSH Terms

Conditions

Prosthesis Failure; Hypoxia; Respiratory Distress Syndrome; COVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 22 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 19, 2023
• Study Start: March 1, 2020
• Primary Completion: December 28, 2021
• Study Completion: December 30, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

MO (1)