Comparison of GMA-Tulip and i-gel supraglottic airway devices in orthopedic trauma surgery: a randomized controlled trial
摘要
Accurate supraglottic airway device (SAD) placement is essential in general anesthesia, particularly in patients with orthopedic trauma who demonstrate unique airway challenges. We compared the novel noninflatable GMA-Tulip with the established second-generation i-gel.
MethodsIn this randomized controlled trial, 198 adult patients who underwent emergency or urgent orthopedic trauma surgery were randomly assigned to receive either the i-gel or the GMA-Tulip. The primary outcome was the rate of correct anatomical alignment (defined as a Grade I or II glottic view), assessed immediately after insertion by using a flexible videoscope. Secondary outcomes included the success rate and time of SAD insertion, oropharyngeal leak pressure (OLP), the ease and time of gastric tube placement, and postoperative complications.
ResultsThe GMA-Tulip provided significantly better initial anatomical alignment than the i-gel (85.3% vs. 65.3%; risk difference 20.0%, 95% CI 7.8–31.5%; P = 0.001), with this significant advantage persisting at 60 min (81.3% vs. 56.6%; P = 0.001) and before device removal (77.4% vs. 53.2%; P < 0.001). Both devices demonstrated comparable overall insertion success rates (99% each) and median insertion times (14 s). OLPs measured at 10 min (in the neutral position and with head rotation) and at 60 min after insertion exhibited no significant between-group differences (all P > 0.05). The gastric tube placement time was shorter in the GMA-Tulip group (median time: 16.0 s vs. 21.0 s; P < 0.001). At 1 h postoperatively, the incidence of sore throat was lower in the GMA-Tulip group (23.7% vs. 33.0%; P = 0.026).
ConclusionIn patients who underwent orthopedic trauma surgery, the GMA-Tulip consistently demonstrated superior anatomical alignment, facilitated easier and faster gastric tube placement, and reduced the incidence of early postoperative sore throat compared with the i-gel.
Trial registrationChinese Clinical Trial Registry (ChiCTR2500104359). Registered on June 16, 2025.
Graphical Abstract