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Comparison of airway management effects between GMA-TULIP laryngeal mask and tracheal intubation in long-duration general anesthesia surgery: A randomized controlled multicenter trial

Comparison of airway management effects between GMA-TULIP laryngeal mask and tracheal intubation in long-duration general anesthesia surgery: A randomized controlled multicenter trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103310
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Establishment of Artificial Airway During the Perioperative Period

Interventions

Group T (Endotracheal Tube Group):Insertion of ETT
Group G (GMA-TULIP Laryngeal Mask Group):Insertion of the GMA-TULIP laryngeal mask

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old=2 hours; 3.18.5<=BMI<=30 kg/m^2; 4. American Society of Anesthesiologists (ASA) grade I.~III; 5. Able to understand the research process and the use of pain scales; 6. Have a clear understanding and voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with known or predicted difficult airway (Mallampati grade > 2 or mouth opening < 3 cm); 2.Patients at high risk of reflux or aspiration (e.g., those with gastroesophageal reflux disease); 3.Patients with active upper respiratory infections; 4.Patients with a history of cervical spine disease or surgery; 5.Patients with preoperative sore throat, or a history of recurrent sore throat or hoarseness; 6.Patients with facial or maxillofacial trauma or fractures; 7.Other reasons deemed by the investigator as unsuitable for participation in the trial;

Design outcomes

Primary

MeasureTime frame
Oropharyngeal Leak Pressure (OLP);

Secondary

MeasureTime frame
General Observation Indicators;Insertion time;Patient's ventilation status;Insertion difficulty;Hemodynamic parameters;The number of laryngeal mask insertions or endotracheal intubations.;Airway Injury and Complications;

Countries

China

Contacts

Public ContactWenjieJin

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

1578852260@qq.com+86 13813043330

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026