Hyperoxia and Pulmonary Complications After Cardiac Surgery | NCT04278066

Studies
Hyperoxia and Pulmonary Complications After Cardiac Surgery

NCT04278066

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Oct 7, 2021Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Hyperoxia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2020Actual

Primary Completion Date

Sep 5, 2020Actual

Completion Date

Sep 5, 2020Actual

First Submitted Date

Feb 17, 2020

First Submission Date that Met QC Criteria

Feb 17, 2020

First Posted Date

Feb 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2021

Last Update Posted Date

Oct 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patient operated heart surgery with extra-corporal life support

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François FISCHER, MD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésiologie - NHC		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D018496	Hyperoxia
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided