NCT03309280

Brief Summary

The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

First Submitted

Initial submission to the registry

October 9, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 9, 2017

Last Update Submit

January 23, 2020

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Time of extubation

    Time when extubation is performed

    2 Days

Study Arms (2)

Patient at risk for OSA scheduled for Cardiac surgery

Patients with a positive STOP-Bang and DES-OSA score (that means patients at risk for OSA)

Other: Duration of intubationDiagnostic Test: Evolution of the renal function

Patient not at risk for OSA scheduled for Cardiac surgery

Patients with a negative STOP-Bang and DES-OSA score (that means patients not at risk for OSA)

Other: Duration of intubationDiagnostic Test: Evolution of the renal function

Interventions

Duration of intubationOTHER

Time between intubation in the operating room and exhumation in the Intensive Care Unit.

Patient at risk for OSA scheduled for Cardiac surgeryPatient not at risk for OSA scheduled for Cardiac surgery
Evolution of the renal functionDIAGNOSTIC_TEST

Evolution of the renal function in the next two days

Patient at risk for OSA scheduled for Cardiac surgeryPatient not at risk for OSA scheduled for Cardiac surgery

Eligibility Criteria

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

All patients scheduled for cardiac surgery in the Saint-Luc Bouge hospital.

You may qualify if:

  • All patients for elective cardiac surgery

You may not qualify if:

  • Emergency procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Bouge, Namur, 5004, Belgium

Location

Study Officials

  • Eric Deflandre

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

October 9, 2017

Primary Completion

April 3, 2018

Study Completion

June 1, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)