NCT05050435

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

August 30, 2021

Last Update Submit

October 5, 2021

Conditions

Post-operative Cardiac Surgery

Keywords

post-operative complicationson table extubation

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    Intensive care unit length of stay (days)

    30 days

Study Arms (2)

Early extubated (in operating room) patients after valvular cardiac surgery

Procedure: Early extubation

Later extubated (in ICU) patients after valvular cardiac surgery

Interventions

Early extubationPROCEDURE

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

Early extubated (in operating room) patients after valvular cardiac surgery

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Combined surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULiege - CHU

Liège, 4000, Belgium

RECRUITING

Central Study Contacts

Oceane Jaquet

CONTACT

0032479760411jaquet.oceane@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 20, 2021

Study Start

August 30, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

BE(1)