Clinical trial NCT06287554: Effect of Early Implementation of Prone Positioning
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome
Keywords: Prone, Lung protective, ARDS, APACHI II, SOFA
Lead sponsor: Zulekha Hospitals
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2024-03-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 124 patients were recruited initially to the study who were admitted with ARDS to the ICU. A total of 70 patients were finally included and divided into two groups,

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of discharged patients
timeFrame: 26 MONTHS
Secondary outcomes:
measure: The total length of stay
timeFrame: 26 MONTHS
measure: ICU length of stay
timeFrame: 26 MONTHS
measure: Patients who underwent tracheostomy procedures
timeFrame: 26 MONTHS
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar faculty of medicine
Study officials:
affiliation: Consultant critical care
name: SAMEH H SEYAM, PHD
role: STUDY_CHAIR
References: