Bariatric Surgery CandidateNCT02324946
Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.
An observational study of Bariatric Surgery Candidate, run by Astes at 1 site in Belgium.
Trial summary
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea. This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Mass Screening
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Dec 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for bariatric surgery
Who may be able to join
- BMI > 30 kg m-2
- Preoperative Polysomnography
Who cannot join
- Pregnant women
- ENT Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation Among Patients Scheduled for Bariatric Surgery.
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.
This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.
Read the detailed description
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.
This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Mass Screening
- Keywords
- Sleep Apnea Syndromes, Perioperative Period, Mass Screening
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass ScreeningOther
Preoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Mass Screening Receives: Other: Mass Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric P DEFLANDRE, MD, FCCP, Study chair, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324946
- Sponsor's protocol ID
- STOP-BANG, DES-OSA
- Status last verified
- Jun 2017
- First submitted
- 19 Dec 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation Among Patients Scheduled for Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT02324946
- Acronym / sponsor ID
- STOP-BANG, DES-OSA
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Sleep Apnea Syndromes, Perioperative Period, Mass Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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.
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.
This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.
Detailed description
The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.
This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Mass ScreeningMass Screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for bariatric surgery
Key inclusion criteria (2 listed)
- BMI > 30 kg m-2
- Preoperative Polysomnography
Key exclusion criteria (2 listed)
- Pregnant women
- ENT Cancer
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 |
|---|---|---|
| Mass ScreeningPreoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores. | Other | Study Group |
Primary outcome
Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation.
Time frame: 1 day
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 2 Jul 2017.
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
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.
Eric P DEFLANDRE, MD, FCCP study chair
Astes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Astes at 1 site in Belgium.
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 2 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 2 Jul 2017. 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 Belgium. 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?
Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation. (time frame: 1 day). 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 2 Jul 2017.