Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

June 16, 2018 updated by: Eric DEFLANDRE, MD, FCCP, Astes
The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications.

STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Study Type

Observational

Enrollment (Actual)

293

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Namur
      • Bouge, Namur, Belgium, 5004
        • Clinique Saint-Luc de Bouge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients enrolling in the preanesthsia visit before elective surgery.

Description

Inclusion Criteria:

  • All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017

Exclusion Criteria:

  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
All patients included in the study. First: clinical scores were collected in all patients. Second: all patients underwent a polysomnography in order to compare this results with these of the clinical scores.
Diagnostic test: Polysomnography
To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of results of clinical scores and results of polysomnography.
Time Frame: 1 night
Comparison of the two results to determine the sensitivity and specificity of each clinical scores in comparison with polysmnography (the gold standard).
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 16, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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