ObesityNCT06265064
STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients
An observational study of Obesity and OSA, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- STOP-Bang score >= 3 with factors predicting difficult intubation
- How many people
- 278 participants
- Where
- 1 siteThailand
- Study dates
- 11 Jul 2022to 31 Oct 2023
- How long will I take part?
- 1 Day
- 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: Calculation by Diagnotic test that used sensitivity and Specificity of the precedent journal "Accuracy of STOP-Bang Questionnaire in Predicting Difficult Mask Ventilation: An Observational Study by Marium N. Khan , Aliya Ahmed" total population 278 patients
Who may be able to join
- BMI ≥ 25 kg/m2
- Age > 18 years old
- undergoing elective surgery under general anesthesia with endotracheal intubation
Who cannot join
- History of difficult mask and intubation
- Maxillofacial or upper airway malformation
- History of C-spine disease such as trauma, degeneration
- Pregnancy
- Rapid sequence induction technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Combination of STOP-Bang Score and Factors Predicting Difficult Intubation Improve Accuracy of Prediction Difficult Mask Ventilation in Obese Patients?
The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.
The main question[s] it aims to answer are:
Read more
- Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?
- Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.
Participants who undergoing to elective surgery under general anesthesia will
- Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)
- In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.
If there is a comparison group:
Researchers will compare obese patients with/without high STOP bang score >=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference > 42 cm, Thyromental distance < 6 cm)to prediction difficult mask ventilation
- Being tested
- STOP-Bang score >= 3 with factors predicting difficult intubation
- Keywords
- mask ventilation, general anesthesia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP-Bang score >= 3 with factors predicting difficult intubationDiagnostic test
patients with STOP-Bang score >= 3 with Mallampati score ≥ 3 or neck circumference >42 cm or mentothyroid distance <6 cm
| Study group | Role | What they receive |
|---|---|---|
| Difficult mask ventilation | Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is ≥ 3, it signifies difficult mask ventilation Receives: Diagnostic Test: STOP-Bang score >= 3 with factors predicting difficult intubation | |
| non-difficult mask ventilation | Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is < 3, it signifies non-difficult mask ventilation Receives: Diagnostic Test: STOP-Bang score >= 3 with factors predicting difficult intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult mask ventilation
Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is ≥ 3, it signifies difficult mask ventilation
Measured: After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.
Secondary outcomes (1)
Resipiratory complication
- Airway trauma
- Desaturation Spo2<90% in 2 minutes
- Regurgitation
- Aspiration
Measured: during mask ventilation until the completion of intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start11 Jul 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 278 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petsiri Thaweewan, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265064
- Sponsor's protocol ID
- KhonKaenUniversity
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Combination of STOP-Bang Score and Factors Predicting Difficult Intubation Improve Accuracy of Prediction Difficult Mask Ventilation in Obese Patients?
- ClinicalTrials.gov ID
- NCT06265064
- Acronym / sponsor ID
- KhonKaenUniversity
- Keywords
- mask ventilation, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 20 Feb 2024 (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.
The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.
The main question[s] it aims to answer are:
- Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?
- Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.
Participants who undergoing to elective surgery under general anesthesia will
- Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)
- In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.
If there is a comparison group:
Researchers will compare obese patients with/without high STOP bang score >=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference > 42 cm, Thyromental distance < 6 cm)to prediction difficult mask ventilation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult mask ventilation | – | Diagnostic Test: STOP-Bang score >= 3 with factors predicting difficult intubationDifficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is ≥ 3, it signifies difficult mask ventilation |
| non-difficult mask ventilation | – | Diagnostic Test: STOP-Bang score >= 3 with factors predicting difficult intubationDifficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is < 3, it signifies non-difficult mask ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Calculation by Diagnotic test that used sensitivity and Specificity of the precedent journal "Accuracy of STOP-Bang Questionnaire in Predicting Difficult Mask Ventilation: An Observational Study by Marium N. Khan , Aliya Ahmed" total population 278 patients
Key inclusion criteria (3 listed)
- BMI ≥ 25 kg/m2
- Age > 18 years old
- undergoing elective surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (5 listed)
- History of difficult mask and intubation
- Maxillofacial or upper airway malformation
- History of C-spine disease such as trauma, degeneration
- Pregnancy
- Rapid sequence induction technique
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 |
|---|---|---|
| STOP-Bang score >= 3 with factors predicting difficult intubationpatients with STOP-Bang score >= 3 with Mallampati score ≥ 3 or neck circumference >42 cm or mentothyroid distance <6 cm | Diagnostic test | Difficult mask ventilation, non-difficult mask ventilation |
Primary outcome
Difficult mask ventilation
Time frame: After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.
Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is ≥ 3, it signifies difficult mask ventilation
1 secondary outcome
Resipiratory complication
Time frame: during mask ventilation until the completion of intubation.
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 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and OSA, run by Khon Kaen University at 1 site in Thailand.
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 3 inclusion and 5 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 20 Feb 2024. 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 Thailand. 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?
Difficult mask ventilation (time frame: After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.). 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 20 Feb 2024.