Relationship Between STOP BANG Score and Airway Management | NCT05640856

Studies
Relationship Between STOP BANG Score and Airway Management

NCT05640856

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Dec 7, 2022Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Airway Obstruction
Obstructive Sleep Apnea
Hypoxia

Interventions

intubation

Countries

Turkey (Türkiye)

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

Nov 2022

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

Jan 1, 2021Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Nov 16, 2022

First Submission Date that Met QC Criteria

Nov 28, 2022

First Posted Date

Dec 7, 2022Actual

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

Nov 28, 2022

Last Update Posted Date

Dec 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bengü Gülhan Köksal, Principal Investigator, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group D		STOP BANG Score <3	Procedure: intubation
Group Y		STOP BANG Score ≥ 3	Procedure: intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intubation	Procedure	Endotracheal tube placement	Group D Group Y

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of Oxygenation	prediction of desaturation by oxygen reserve index in patients with low and high risk of OSAS	up to intubation

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of difficult Airway	using mask-ventilation scale in patients with low and high risk of OSAS	up to intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18-65 to be intubated undergoing elective surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University Medicine Faculty		Zonguldak	Kozlu	67600	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000402	Airway Obstruction
D020181	Sleep Apnea, Obstructive
D000860	Hypoxia

Ancestor Terms

ID	Term
D012131	Respiratory Insufficiency
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012891	Sleep Apnea Syndromes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007440	Intubation

Ancestor Terms

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided