Comparison of STOP-BANG and DES-OSA as Predictive Score f... | NCT02324946

Studies
Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.

NCT02324946

Sponsor

Astes

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Bariatric Surgery Candidate

Interventions

Mass Screening

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

Jun 2017

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

Oct 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 19, 2014

First Submission Date that Met QC Criteria

Dec 23, 2014

First Posted Date

Dec 24, 2014Estimated

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

Jun 28, 2017

Last Update Posted Date

Jul 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 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.

Detailed Description

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 mask ventilation of tracheal intubation.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Mass Screening	Other: Mass Screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mass Screening	Other	Preoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation.		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI > 30 kg m-2
Preoperative Polysomnography

Exclusion Criteria:

Pregnant women
ENT Cancer

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

Patients scheduled for bariatric surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric P DEFLANDRE, MD, FCCP	Astes	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint-Luc de Bouge		Bouge	Namur	5004	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided