Effect of Early Implementation of Prone Positioning

Severe Acute Respiratory Syndrome Clinical Trial

— prone  

Official title:

Effect of Early Implementation of Prone Positioning Among Critically Ill Patients Admitted With Acute Respiratory Distress Syndrome During the COVID-19 Time: A Comparative Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06287554
• Other study ID #: 404/2024
• Status: Completed
• Start date: March 4, 2020
• Est. completion date: April 20, 2022

Study information

• Verified date: February 2024
• Source: Zulekha Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Other:
• PRONE POSITION
early placed in prone positions within 24 hours of intubation

Locations

Country	Name	City	State
Egypt	Al-Azhar faculty of medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Zulekha Hospitals	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of discharged patients	Number of discharged patients	26 MONTHS
Secondary	The total length of stay	The total length of stay	26 MONTHS
Secondary	ICU length of stay	ICU length of stay	26 MONTHS
Secondary	Patients who underwent tracheostomy procedures	Patients who underwent tracheostomy procedures	26 MONTHS