HypoxiaNCT03838705
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool
A study testing hypoxia and normooxy in people with Hypoxia and Bariatric Surgery, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Bariatric Surgery
- What is being tested?
- hypoxia and normooxy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>40
- bariatric surgery patients
Who cannot join
- malignancy
- patients who are unable to complete the questionnaire
- patients who needs laparotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients
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.
- Conditions
- Hypoxia, Bariatric Surgery
- Being tested
- hypoxia, normooxy
- Keywords
- stop-bang, bariatric surgery, obesity, hypoxia
- Medical subject headings
- Hypoxia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxiaProcedure or surgery
It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.
normooxyProcedure or surgery
It was accepted that patients with SpO2 between 100-92 mmHg
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery patients | Other | patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation Receives: Procedure: hypoxia; Procedure: normooxy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
Peripheral Oxygen Saturation
Measured: 48 hours
Secondary outcomes (2)
STOP-BANG
The value of STOP-BANG questionnaire
Measured: preoperative 24 hours
4-V Tool
The value of 4-V Tool
Measured: preoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start20 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Sibel Ocak Serin, Aysun Isiklar
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Sibel O Serin, MD, Study director, Umraniye Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838705
- Sponsor's protocol ID
- SS1
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03838705
- Acronym / sponsor ID
- SS1
- Conditions
- Hypoxia, Bariatric Surgery
- Keywords
- stop-bang, bariatric surgery, obesity, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Collaborators
- Sibel Ocak Serin, Aysun Isiklar
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery patients | Other | Procedure: hypoxia, Procedure: normooxypatients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI>40
- bariatric surgery patients
Key exclusion criteria (3 listed)
- malignancy
- patients who are unable to complete the questionnaire
- patients who needs laparotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoxiaIt was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values. | Procedure or surgery | bariatric surgery patients |
| normooxyIt was accepted that patients with SpO2 between 100-92 mmHg | Procedure or surgery | bariatric surgery patients |
Primary outcome
SpO2
Time frame: 48 hours
Peripheral Oxygen Saturation
2 secondary outcomes
STOP-BANG
Time frame: preoperative 24 hours
4-V Tool
Time frame: preoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel O Serin, MD study director
Umraniye Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia and normooxy in people with Hypoxia and Bariatric Surgery, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.