NCT05640856

Brief Summary

Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
Last Updated

December 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

November 16, 2022

Last Update Submit

November 28, 2022

Conditions

Keywords

Oxygen Reserve IndexSTOP BANG ScoreDifficult Airway

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Oxygenation

    prediction of desaturation by oxygen reserve index in patients with low and high risk of OSAS

    up to intubation

Secondary Outcomes (1)

  • Evaluation of difficult Airway

    up to intubation

Study Arms (2)

Group D

STOP BANG Score \<3

Procedure: intubation

Group Y

STOP BANG Score ≥ 3

Procedure: intubation

Interventions

intubationPROCEDURE

Endotracheal tube placement

Group DGroup Y

Eligibility Criteria

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

Patients aged 18-65 to be intubated undergoing elective surgery

You may qualify if:

  • American Society of Anesthesiologists (ASA) I-III
  • Between 18-65 years old
  • Volunteered to participate in the study

You may not qualify if:

  • diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS
  • morbidly obese (BMI\>45 kg/m2),
  • patients with a history of alcohol or drug addiction
  • women in pregnancy or lactation
  • allergic to the drugs used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Airway ObstructionSleep Apnea, ObstructiveHypoxia

Interventions

Intubation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesApneaSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 7, 2022

Study Start

January 1, 2021

Primary Completion

June 30, 2022

Study Completion

November 1, 2022

Last Updated

December 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations