The Relationship Between Postoperative Oxygenation and ST... | NCT03838705

Studies
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool

NCT03838705

Sponsor

Umraniye Education and Research Hospital

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Hypoxia
Bariatric Surgery

Interventions

hypoxia
normooxy

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

Feb 2019

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 20, 2018Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

Feb 10, 2019

First Submission Date that Met QC Criteria

Feb 10, 2019

First Posted Date

Feb 12, 2019Actual

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

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gulsah Karaoren, Associate professor, Umraniye Education and Research HospitalPrincipal Investigator

Lead Sponsor

Umraniye Education and Research HospitalOTHER_GOV

Collaborators

Name	Class
Sibel Ocak Serin	UNKNOWN
Aysun Isiklar	UNKNOWN

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

In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable Screening questionnaires in postoperative period in patients who underwent bariatric surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bariatric surgery patients	Other	patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation	Procedure: hypoxia Procedure: normooxy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypoxia	Procedure	It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.	bariatric surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SpO2	Peripheral Oxygen Saturation	48 hours

Secondary Outcomes

Measure	Description	Time Frame
STOP-BANG	The value of STOP-BANG questionnaire	preoperative 24 hours
4-V Tool	The value of 4-V Tool	preoperative 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>40
bariatric surgery patients

Exclusion Criteria:

malignancy
patients who are unable to complete the questionnaire
patients who needs laparotomy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sibel O Serin, MD	Umraniye Research Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Umraniye Training Hospital		Istanbul			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
D000860	Hypoxia
D009765	Obesity

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided