We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours

July 30, 2024 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

''Impact of Early vs. Delayed Prone Positioning on Oxygenation and Mortality in COVID-19 ARDS Patients: A Retrospective Analysis''

The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.

Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34450
        • Bakirkoy Dr Sadi Konuk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have been admitted in ICU and diagnosed with Covid-19 ARDS.

Description

Inclusion Criteria:

COVİD 19 ARDS patients patients who have been intubated for 48 hours and more

Exclusion Criteria:

Pediatric patients Patients who extubated in less than 48 hours Patients with Lung and pleural malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients who have been in prone positioning for 16-24 hours
Other: prone positioning
prone positioning
Group B
Patients who have been in prone positioning for 24-48 hours
Other: prone positioning
prone positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation Index (OSI)
Time Frame: 48 hours
OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2
48 hours
Oxygenation Index
Time Frame: 48 hours
Oxygenation index is calculated as OI = MAP × Fio2 × 100 / Pao2, where MAP indicates mean airway pressure and Fio2 indicates fraction of inspired oxygen
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: 28 days
mortality rates during patients admission in the ICU
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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