Comparing three devices for airway management during anesthesia
GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study
This study tests which of three airway devices works best for patients having elective breast or lower abdominal surgery to help them breathe safely during anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 498 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06383494 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of three supraglottic airway devices (LMA Supreme, I-gel, and GMA-Tulip) in managing the airway of patients undergoing elective breast or lower abdominal surgery. Patients are randomly assigned to one of the three device groups, and their airway management quality is assessed using fiberoptic bronchoscopy to grade glottic exposure. Key metrics such as peak airway pressure, incidence of complications like pharyngalgia and hoarseness, and overall ventilation quality are recorded to determine the best device for airway management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with ASA physical status I-III, scheduled for elective surgery lasting less than 4 hours.
Not a fit: Patients with a history of oropharyngeal surgery, anatomical abnormalities, or those at high risk for reflux/aspiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance airway management techniques, leading to improved patient safety and outcomes during anesthesia.
How similar studies have performed: Previous studies have shown varying success with different supraglottic airway devices, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years old; * American Society of Anesthesiologists (ASA) I-III; * Body mass index (BMI)\<30Kg/m2; * Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours; * Providing written inform consent. Exclusion Criteria: * History of oropharyngeal surgery and anatomical abnormalities; * Limited movement of the cervical spine; * High risk of reflux/aspiration; * Emergency surgery; * Acute throat inflammation and upper respiratory infection; * History of chronic bronchitis or asthma; * Cognitive dysfunction and inability to communicate; * Participating in other clinical trials.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jiangling Wang, Ph. D — Zhejiang Cancer Hospital
- Study coordinator: Jiangling Wang, Ph.D
- Email: wangjl@zjcc.org.cn
- Phone: +86 571 88122106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.