Effect of Early Implementation of Prone Positioning

Completed

• Conditions: Severe Acute Respiratory Syndrome
• Interventions: Other: PRONE POSITION

• Registration Number: NCT06287554
• Lead Sponsor: Zulekha Hospitals

Brief Summary

Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.

Detailed Description

Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU.

Methodology: This retrospective study was conducted on critically ill patients needing mechanical ventilation with lung protective strategy and admitted to the Intensive Care Units of Al-Azhar University Hospitals between March 2020 to April 2022. All patients in the study were interpreted retrospectively by examining the patient's records. Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation, and Group B (n:31) included patients who had not been placed in prone positions. All patients received a lung protective strategy for ARDS. In both groups, PaO2, PaCo2, PH, SpO2, and PaO2/FiO2 ratio were checked initially and later every 24 hours for 6 days. All patients were evaluated for the total days of both hospital and ICU length of stay, number of successful discharges to home from the hospital, and the total number of tracheostomized patients.

Study Timeline

• Study Start: 2020-03-04
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• All patients of both sexes.
• Aged from 18 to 70 years.
• Body Mass Index (BMI) from 25 to 35 kg/m2.
• Critically ill due to ARDS resulting from COVID-19 pneumonia.

Exclusion Criteria

• Patients who spent more than 24 hours on mechanical ventilators before enrolment in the study.
• Patients who died within the first 24 hours of presentation.
• Patients with advanced cancer.
• Pregnant patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	PRONE POSITION	Group A (n:39) included patients who had been early placed in prone positions within 24 hours of intubation

Primary Outcome Measures

Name	Time	Method
Number of discharged patients	26 MONTHS	Number of discharged patients

Secondary Outcome Measures

Name	Time	Method
Patients who underwent tracheostomy procedures	26 MONTHS	Patients who underwent tracheostomy procedures
ICU length of stay	26 MONTHS	ICU length of stay
The total length of stay	26 MONTHS	The total length of stay

Trial Locations

Locations (1)

Al-Azhar faculty of medicine; 🇪🇬 Cairo, Egypt