NCT06530095

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

MoralityOxygenation IndicesHypoxia

Outcome Measures

Primary Outcomes (2)

  • Oxygen Saturation Index (OSI)

    OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2

    48 hours

  • Oxygenation Index

    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 Outcomes (1)

  • ICU mortality

    28 days

Study Arms (2)

Group A

Patients who have been in prone positioning for 16-24 hours

Other: prone positioning

Group B

Patients who have been in prone positioning for 24-48 hours

Other: prone positioning

Interventions

prone positioningOTHER

prone positioning

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi konuk Research and Training hospital

Istanbul, 34450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

July 31, 2024

Study Start

October 3, 2022

Primary Completion

January 3, 2023

Study Completion

February 15, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)