- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05387356
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU
May 23, 2022 updated by: ESRA OZAYAR, Kecioren Education and Training Hospital
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU: A Retrospective Study
Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included.
Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning.
Eye, skin, nerve and tube complications related to prone positions wll be recorded
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
31
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
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Ankara, Turkey
- Recruiting
- Health Sciences University
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Contact:
- esra ozayar
- Phone Number: 905055025497
- Email: eozayar@yahoo.com.tr
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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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Intensive care patient population who were intubated a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study.
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Description
Inclusion Criteria:
a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -
Exclusion Criteria:
negative test result for SARS-CoV-2 RNA -
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effects of prone position
Time Frame: 15 days
|
The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position
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15 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 23, 2022
Primary Completion (Anticipated)
June 10, 2022
Study Completion (Anticipated)
June 10, 2022
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 24, 2022
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prone position
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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