Validation of Safety and Efficacy of a Novel Multichannel Flexible Laryngeal Mask Airway in Nasal Surgery: A Single-Center, Prospective, Observational, Cohort Study

Clinical Verification of the Enhanced Safety of a Multi-channel Laryngeal Mask Airway

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500106750

Enrollment

Unknown

Registered

2025-07-29

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Airway management

Interventions

Observation group:None

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 Patients scheduled for nasal surgery under general anesthesia; 2 Aged 18 to 60 years; 3 ASA physical status I or II; 4 BMI 18~30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1 BMI > 30 kg/m^2; 2 Anticipated difficult airway; 3 Patients requiring tracheal intubation due to surgical needs; 4 Co-existing acute or chronic respiratory diseases, such as acute upper respiratory tract infection, asthma, or COPD; 5 Patients with risk factors for reflux, such as delayed gastric emptying or gastroesophageal reflux.

Design outcomes

Primary

Measure	Time frame
Pharyngeal saline recovery;Airwayl leak pressure;	—

Secondary

Measure	Time frame
The ease of Mc-FLMA placement ;The time for successful insertion of Mc-FLMA;The ease of gastric tube placement;The time for successful gastric tube placement;Success rates;Fibre-optic grading scale;The quality of airway and complications;Postoperative follow-up;	—

Countries

China

Contacts

Public ContactWenxian Li

Eye & ENT Hospital of Fudan University

liwenxian@eentanesthesia.com+86 139 1742 6838

Outcome results

None listed

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