- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530095
We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours
''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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34450
- Bakirkoy Dr Sadi Konuk Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
prone positioning
|
|
Group B
Patients who have been in prone positioning for 24-48 hours
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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