Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03838705
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Sibel Ocak Serin
Aysun Isiklar
Information provided by (Responsible Party):
Gulsah Karaoren, Umraniye Education and Research Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypoxia Bariatric Surgery Procedure: hypoxia Procedure: normooxy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients
Actual Study Start Date : January 20, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
bariatric surgery patients
patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation
 Procedure: hypoxia
It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.

Procedure: normooxy
It was accepted that patients with SpO2 between 100-92 mmHg


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. SpO2 [ Time Frame: 48 hours ]
    Peripheral Oxygen Saturation


Secondary Outcome Measures :
  1. STOP-BANG [ Time Frame: preoperative 24 hours ]
    The value of STOP-BANG questionnaire

  2. 4-V Tool [ Time Frame: preoperative 24 hours ]
    The value of 4-V Tool


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI>40
  • bariatric surgery patients

Exclusion Criteria:

  • malignancy
  • patients who are unable to complete the questionnaire
  • patients who needs laparotomy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838705


Locations
Layout table for location information
Turkey
Istanbul Umraniye Training Hospital
Istanbul, Turkey
Sponsors and Collaborators
Umraniye Education and Research Hospital
Sibel Ocak Serin
Aysun Isiklar
Investigators
Layout table for investigator information
Study Director: Sibel O Serin, MD Umraniye Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gulsah Karaoren, Associate professor, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03838705    
Other Study ID Numbers: SS1
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gulsah Karaoren, Umraniye Education and Research Hospital:
stop-bang, bariatric surgery, obesity, hypoxia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoxia
Signs and Symptoms, Respiratory