NCT03838705

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 10, 2019

Last Update Submit

February 12, 2019

Conditions

HypoxiaBariatric Surgery

Keywords

stop-bang, bariatric surgery, obesity, hypoxia

Outcome Measures

Primary Outcomes (1)

  • SpO2

    Peripheral Oxygen Saturation

    48 hours

Secondary Outcomes (2)

  • STOP-BANG

    preoperative 24 hours

  • 4-V Tool

    preoperative 24 hours

Study Arms (1)

bariatric surgery patients

OTHER

patients aged 18-65 years with ASA status II-III, BMI\>40 who were undergoing bariatric surgery operation

Procedure: hypoxiaProcedure: normooxy

Interventions

hypoxiaPROCEDURE

It was accepted that hypoxia developed in patients with SpO2\< 92 or falling over 20% compared to preoperative values.

bariatric surgery patients
normooxyPROCEDURE

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

bariatric surgery patients

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>40
  • bariatric surgery patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypoxiaObesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Sibel O Serin, MD

    Umraniye Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 10, 2019

First Posted

February 12, 2019

Study Start

January 20, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)