Back to resultsThe Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool
Primary Purpose
Hypoxia, Bariatric Surgery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
hypoxia
normooxy
Sponsored by
About this trial
This is an interventional screening trial for Hypoxia focused on measuring stop-bang, bariatric surgery, obesity, hypoxia
Eligibility Criteria
Inclusion Criteria:
- BMI>40
- bariatric surgery patients
Exclusion Criteria:
- malignancy
- patients who are unable to complete the questionnaire
- patients who needs laparotomy
Sites / Locations
- Istanbul Umraniye Training Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
bariatric surgery patients
Arm Description
patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation
Outcomes
Primary Outcome Measures
SpO2
Peripheral Oxygen Saturation
Secondary Outcome Measures
STOP-BANG
The value of STOP-BANG questionnaire
4-V Tool
The value of 4-V Tool
Full Information
NCT ID
NCT03838705
First Posted
February 10, 2019
Last Updated
February 12, 2019
Sponsor
Umraniye Education and Research Hospital
Collaborators
Sibel Ocak Serin, Aysun Isiklar
1. Study Identification
Unique Protocol Identification Number
NCT03838705
Brief Title
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool
Official Title
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umraniye Education and Research Hospital
Collaborators
Sibel Ocak Serin, Aysun Isiklar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Bariatric Surgery
Keywords
stop-bang, bariatric surgery, obesity, hypoxia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bariatric surgery patients
Arm Type
Other
Arm Description
patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation
Intervention Type
Procedure
Intervention Name(s)
hypoxia
Intervention Description
It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.
Intervention Type
Procedure
Intervention Name(s)
normooxy
Intervention Description
It was accepted that patients with SpO2 between 100-92 mmHg
Primary Outcome Measure Information:
Title
SpO2
Description
Peripheral Oxygen Saturation
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
STOP-BANG
Description
The value of STOP-BANG questionnaire
Time Frame
preoperative 24 hours
Title
4-V Tool
Description
The value of 4-V Tool
Time Frame
preoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>40
bariatric surgery patients
Exclusion Criteria:
malignancy
patients who are unable to complete the questionnaire
patients who needs laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel O Serin, MD
Organizational Affiliation
Umraniye Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Umraniye Training Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool
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