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A comparative study of laryngeal mas-related complications between GMA Tulip laryngeal mask and SaCoVLMTM visual laryngeal mask during general anesthesia

A comparative study of laryngeal mas-related complications between GMA Tulip laryngeal mask and SaCoVLMTM visual laryngeal mask during general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118515
Enrollment
Unknown
Registered
2026-02-06
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

None

Interventions

Group S :SaCoVLMTM visual laryngeal mask
Group G :GMA-TULIP laryngeal mask

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients and their legal representatives voluntarily participate in the study and sign an informed consent form; 2.Patients undergoing general anesthesia with intravenous inhalation at each center hospital; 3.American Anesthesiologists Association (ASA) grade I-II; age 18-70 years old, BMI 18-30kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Accompanied by severe respiratory diseases; 2. Full stomach or with a clear risk of reflux aspiration; 3. Pregnancy; 4. Head and neck tumors or abnormal mobility, oropharyngeal malformations or pharyngeal inflammation, Mallampati class IV, thyromental distance =35 kg/m^2), severe obstructive sleep apnea syndrome; 5. Accompanied by dysfunction of other important organs, including severe liver and kidney dysfunction; organic brain diseases, specifically aneurysmal vascular diseases or arteriovenous malformations and cerebral hemorrhage; severe hypertension, coronary artery disease, heart failure (NYHA >= III), pulmonary hypertension; hematologic diseases; coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Within 2 hours after surgery, the incidence of laryngeal mask related complications such as sore throat, blood staining of laryngeal mask, reflux aspiration, dysphagia, hoarseness, etc. (one occurrenc;

Secondary

MeasureTime frame
Laryngeal mask insertion time and the success rate of initial insertion;Oropharyngealleak pressure;Airway assessment (including mouth opening, Malampati grading, nail chin distaailnceHead and neck range of motion);Fiber bronchoscopy examination alignment grading;

Countries

China

Contacts

Public ContactChaojin Chen

Third Affiliated Hospital of Sun Yat-sen University

chenchj28@mail.sysu.edu.cn+86 13430322182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026