Early Cardiac Extubation After Cardiac Surgery | NCT05050435

Studies
Early Cardiac Extubation After Cardiac Surgery

NCT05050435

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Oct 14, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Post-operative Cardiac Surgery

Interventions

Early extubation

Countries

Belgium

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Aug 30, 2021

First Submission Date that Met QC Criteria

Sep 14, 2021

First Posted Date

Sep 20, 2021Actual

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 5, 2021

Last Update Posted Date

Oct 14, 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 management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability This evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. In particular, immediate postoperative extubation appeared feasible. The investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. The investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early extubated (in operating room) patients after valvular cardiac surgery			Procedure: Early extubation
Later extubated (in ICU) patients after valvular cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early extubation	Procedure	Patients of the 2 groups are extubated at different moments: either immediately postoperatively, in the operating room, or after a few hours monitoring in ICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative complications	Intensive care unit length of stay (days)	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minimally invasive valve replacement intervention (thoracotomy or J-hemisternotomy)

Exclusion Criteria:

Combined surgery

Accepts Healthy Volunteers

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

We included all the patients who have had minimally invasive valve replacement surgery in our service

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oceane Jaquet	Contact	0032479760411		jaquet.oceane@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ULiege - CHU	Recruiting	Liège		4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided