NCT04278066

Brief Summary

The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

February 5, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
Last Updated

October 7, 2021

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 17, 2020

Last Update Submit

October 6, 2021

Conditions

Hyperoxia

Keywords

HyperoxiaCardiac surgerypulmonary complicationsLung collapsePost-operative

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of the average of per and postoperative PaO2 in cardiac surgery

    iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient operated heart surgery with extra-corporal life support

You may qualify if:

  • 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

You may not qualify if:

  • Non-consent patient
  • Hypoxemic patient
  • Emergency surgery
  • Patient with post-operative cardiac assist device
  • Patient with guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésiologie - NHC

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

HyperoxiaPulmonary Atelectasis

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract Diseases

Study Officials

  • François FISCHER, MD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

February 5, 2020

Primary Completion

September 5, 2020

Study Completion

September 5, 2020

Last Updated

October 7, 2021

Record last verified: 2020-02

Locations

FR(1)