- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278066
Hyperoxia and Pulmonary Complications After Cardiac Surgery (HYPER-CARDIO)
October 6, 2021 updated by: University Hospital, Strasbourg, France
Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery
The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
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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Strasbourg, France, 67091
- Service d'Anesthesiologie - NHC
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patient operated heart surgery with extra-corporal life support
Description
Inclusion Criteria:
- Adult patient (≥18 years old)
- Patient operated heart surgery with extra-corporal life support
- Hospitalization in Cardiology intensive and critical care unit
- Patient operated in HUS between 01/01/2015 and 31/12/2019
- Subject consent, after information, to the reuse of its data for the purposes of this study
Exclusion Criteria:
- Non-consent patient
- Hypoxemic patient
- Emergency surgery
- Patient with post-operative cardiac assist device
- Patient with guardianship
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retrospective study of the average of per and postoperative PaO2 in cardiac surgery
Time Frame: iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined
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iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: François FISCHER, MD, University Hospital, Strasbourg, France
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)
February 5, 2020
Primary Completion (ACTUAL)
September 5, 2020
Study Completion (ACTUAL)
September 5, 2020
Study Registration Dates
First Submitted
February 17, 2020
First Submitted That Met QC Criteria
February 17, 2020
First Posted (ACTUAL)
February 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 7, 2021
Last Update Submitted That Met QC Criteria
October 6, 2021
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7655
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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