Effect of Early Implementation of Prone Positioning

NCT06287554 | Completed

• 1 other identifier: 404/2024
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome

Keywords

Prone, Lung protective, ARDS, APACHI II, SOFA

Outcome Measures

Primary Outcomes (1)

• Number of discharged patients

  Number of discharged patients

  26 MONTHS

Secondary Outcomes (3)

• The total length of stay

  26 MONTHS

• ICU length of stay

  26 MONTHS

• Patients who underwent tracheostomy procedures

  26 MONTHS

Study Arms (2)

Group A

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

Other: PRONE POSITION

Group B

Group B (n:31) included patients who had not been placed in prone position

Interventions

PRONE POSITION OTHER

early placed in prone positions within 24 hours of intubation

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zulekha Hospitals: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• SAMEH H SEYAM, PHD

  Consultant critical care

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 26 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 4, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

EG (1)