- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07493356
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Enhancing Difficult Airway Prediction in Obese Patients: Integrating STOP-BANG With Additional Airway Assessment Tools
This study is being done to determine the diagnostic accuracy of the STOP-BANG questionnaire in predicting difficult mask ventilation and intubation among obese patients.
During the preoperative assessment, eligible participants will be enrolled in the study. The modified Mallampati score, thyromental distance, mouth opening, and upper lip bite tests will be performed along with STOP-Bang scores.
Later in the operating room, general anesthesia will be given, and bag-mask ventilation and intubation grade will be assessed and recorded. A correlation will be assessed between the difficult airway assessment findings, along with the STOP-BANG score and the bas-mask difficulty scores and intubation grades.
Study Overview
Status
Detailed Description
After approval of the Ethical Review Committee (ERC), the study will commence. Participants will be selected from the scheduled elective surgical lists of all surgical departments. Written informed consent will be acquired from all study participants. The resident will document demographic variables (age, height, weight, and gender) and STOP-Bang scores during the pre-anesthesia assessment for eligible participants. A STOP-Bang score of ≥ 3 will suggest a higher risk for difficult airway, whereas a score of < 3 will suggest a lower risk. Anesthesia residents under the supervision of a consultant anesthesiologist will record intraoperative observations on a study form. A qualified anesthesia provider performing bag-mask ventilation must have at least three years of anesthesia experience. The primary investigator will gather the questionnaire and intraoperative data form from the trained anesthesiologist. The anesthesiologist managing the airway will be unaware of the STOP-Bang score. Standard monitoring (ECG, non-invasive blood pressure, and peripheral oxygen saturation) will be attached, and baseline readings will be recorded. Pre-oxygenation will be performed for three minutes. Anesthesia will be induced with nalbuphine 100 micrograms/kg and propofol 2 mg/kg until the patient becomes unresponsive to verbal communication; atracurium 0.6 mg/kg will be given after assessing ventilation. Mask ventilation will be carried out for three minutes with the patient's head in the sniffing position. The supervising consultant will decide when to intervene if the primary anesthetist is unable to mask ventilate the patient.
Following three minutes of mask ventilation, the trachea will be intubated using a Macintosh laryngoscope. The endotracheal tube's correct position will be confirmed by monitoring a persistent end-tidal CO₂ waveform, visible chest rise, and bilateral chest auscultation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Syed M Abbas, FCPS
- Phone Number: 2193 02199215718
- Email: smabbas69@hotmail.com
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan, 74200
- Recruiting
- Sindh Institute of urology and Transplantation
-
Contact:
- Syed M Abbas, FCPS
- Phone Number: +923331318838
- Email: smabbas69@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Male & Female aged 18-60 years.
- Body mass index 30 or more
- American Society of Anesthesiologists (ASA) status II-III.
- Scheduled for elective surgery under general anesthesia with endotracheal intubation.
Description
Inclusion Criteria:
- Male & Female aged 18-60 years.
- Body mass index 30 or more
- American Society of Anesthesiologists (ASA) status II-III.
- Scheduled for elective surgery under general anesthesia with endotracheal intubation.
Exclusion Criteria:
- Patients' refusal to participate.
- American Society of Anesthesiologists (ASA) IV & V.
- Neuromuscular diseases or facial abnormalities.
- Cardiothoracic, head and neck, or emergency surgery.
- Previously diagnosed with OSA (by polysomnography) will be excluded.
- Any airway-related anatomical deformity (e.g., Down's syndrome).
- History of radiation exposure.
- Patient with mouth opening <2 fingers
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adequate Bag-Mask Ventilation
Time Frame: Only once, after giving general anesthesia but before an endotracheal tube is put in the trachea
|
When an anesthetized patient is being manually ventilated by an anesthesia bag and a face mask and achieving a tidal volume of 5 ml/kg, it will be called adequate mask ventilation.
|
Only once, after giving general anesthesia but before an endotracheal tube is put in the trachea
|
|
Difficult Tracheal Intubation
Time Frame: Only once, after giving general anesthesia and 3-minute bag-mask ventilation for adequate muscle relaxation effect, then direct laryngoscopy will be performed to put the endotracheal tube in the trachea
|
Difficult tracheal intubation will be defined as, one that requires external laryngeal manipulation, laryngoscopy requiring more than 3 attempts at intubation, intubation requiring nonstandard equipment or approaches, or the inability to intubate at all
|
Only once, after giving general anesthesia and 3-minute bag-mask ventilation for adequate muscle relaxation effect, then direct laryngoscopy will be performed to put the endotracheal tube in the trachea
|
Collaborators and Investigators
Investigators
- Principal Investigator: Syed M Abbas, FCPS, Sindh Institute of urology and Transplantation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SIUT-ERC-2025/A-587
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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