Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07493356

Difficult Airway Prediction by Integrating STOP-BANG Criteria

Enhancing Difficult Airway Prediction in Obese Patients: Integrating STOP-BANG With Additional Airway Assessment Tools

Status
Recruiting
Phase
Study type
Observational
Enrollment
233 (estimated)
Sponsor
Sindh Institute of Urology and Transplantation · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers

Summary

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.

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.

Conditions

Timeline

Start date
2026-03-09
Primary completion
2026-09-08
Completion
2026-09-08
First posted
2026-03-25
Last updated
2026-03-25

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07493356. Inclusion in this directory is not an endorsement.