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Comparison of airway management differences between I-gel laryngeal mask and double-lumen cuffed laryngeal mask in pediatric general anesthesia: A prospective, multicenter, randomized, parallel controlled study

Comparison of airway management differences between I-gel laryngeal mask and double-lumen cuffed laryngeal mask in pediatric general anesthesia: A prospective, multicenter, randomized, parallel controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113399
Enrollment
Unknown
Registered
2025-11-27
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Clinical effects of two types of laryngeal masks

Interventions

Double-lumen cuffed oropharyngeal airway (control group):General anesthesia with a double-lumen cuffed laryngeal mask
I-gel laryngeal mask general anesthesia (experimental group):General anesthesia with i-gel laryngeal mask

Sponsors

Guangzhou Women and Children's Medical Center, Affiliated to Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 12 Years

Inclusion criteria

Inclusion criteria: Patients aged 0 - 12 years undergoing laryngeal mask general anesthesia, the ASA (American Society of Anesthesiologists) physical status classification is grade I - II, and the Mallampati classification is grade I - II; no history of upper respiratory tract infection within one week; and no history of surgery on the pharynx, oral cavity, trachea, etc.

Exclusion criteria

Exclusion criteria: History of laryngeal mask anesthesia, fever >=39°C, combined with other infections; severe cardiopulmonary diseases or liver and kidney dysfunction; anticipated difficult airway; lesions in the pharyngeal area; risk of gastric reflux, such as full stomach or relevant digestive system diseases like gastroesophageal reflux disease; intraoperative and postoperative use of non-steroidal anti-inflammatory drugs (e.g., flurbiprofen axetil, parecoxib sodium, etc.).

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure (laryngeal mask seal pressure);Laryngeal mask.blood stained ;

Secondary

MeasureTime frame
The first-attempt success rate of laryngeal mask insertion;The incidence of laryngeal mask displacement during surgery;Endoscopic view grading of the laryngeal mask under fiberoptic bronchoscope;Respiratory complications;

Countries

China

Contacts

Public ContactSong Xingrong

Guangzhou Women and Children's Medical Center, Affiliated to Guangzhou Medical University

sxjess@126.com+86 139 2241 6303

Outcome results

None listed

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