NCT02324946

Brief Summary

The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea. This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

December 19, 2014

Last Update Submit

June 28, 2017

Conditions

Bariatric Surgery Candidate

Keywords

Sleep Apnea SyndromesPerioperative PeriodMass Screening

Outcome Measures

Primary Outcomes (1)

  • Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation.

    1 day

Study Arms (1)

Study Group

Mass Screening

Other: Mass Screening

Interventions

Mass ScreeningOTHER

Preoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores.

Study Group

Eligibility Criteria

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

Patients scheduled for bariatric surgery

You may qualify if:

  • BMI \> 30 kg m-2
  • Preoperative Polysomnography

You may not qualify if:

  • Pregnant women
  • ENT Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc de Bouge

Bouge, Namur, 5004, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Eric P DEFLANDRE, MD, FCCP

    Astes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric Deflandre, MD, FCCP

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

BE(1)