Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07493356
Brief 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.
Study:
NCT07493356
Study Brief:
Protocol Section:
NCT07493356