HyperoxiaHYPER-CARDIONCT04278066
Hyperoxia and Pulmonary Complications After Cardiac Surgery
An observational study of Hyperoxia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2020to 5 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient operated heart surgery with extra-corporal life support
Who may be able to join
- 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
Who cannot join
- Non-consent patient
- Hypoxemic patient
- Emergency surgery
- Patient with post-operative cardiac assist device
- Patient with guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hyperoxia
- Keywords
- Hyperoxia, Cardiac surgery, pulmonary complications, Lung collapse, Post-operative
- Medical subject headings
- Hyperoxia, Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the average of per and postoperative PaO2 in cardiac surgery
Measured: iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start5 Feb 2020
- Primary completion5 Sep 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François FISCHER, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278066
- Sponsor's protocol ID
- 7655
- Acronym
- HYPER-CARDIO
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04278066
- Acronym / sponsor ID
- HYPER-CARDIO / 7655
- Conditions
- Hyperoxia
- Keywords
- Hyperoxia, Cardiac surgery, pulmonary complications, Lung collapse, Post-operative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient operated heart surgery with extra-corporal life support
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Non-consent patient
- Hypoxemic patient
- Emergency surgery
- Patient with post-operative cardiac assist device
- Patient with guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
Related trials for Hyperoxia
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Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François FISCHER, MD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperoxia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.