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Comparison of the effects of laryngeal mask and endotracheal tube on respiratory adverse events in pediatric tonsil and adenoid surgery: a randomized, controlled, multicenter clinical trial

Comparison of the effects of laryngeal mask and endotracheal tube on respiratory adverse events in pediatric tonsil and adenoid surgery: a randomized, controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071399
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-05-24
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Adenoid and tonsil hypertrophy

Interventions

Group 1:Use the laryngeal mask to maintain ventilation
Group 2:Use the endotracheal catheter to maintain ventilation

Sponsors

Eye and ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children undergoing tonsillectomy and adenoidectomy selectively under general anesthesia; 2. Children aged from 2 years old to 7 years old; 3. ASA classification I to II; 4. Parents or guardians are willing to consent.

Exclusion criteria

Exclusion criteria: 1. Participants with upper respiratory tract infection and pneumonia in the past 1 week; 2. The onset of asthma or bronchitis; 3. History of gastroesophageal reflux; 4. History of stunted growth; 5. There are serious respiratory, cardiovascular, nervous system abnormalities; 6. Other airway surgeries or combined surgeries were performed during the study period; 7. Children with severe OSA.

Design outcomes

Primary

MeasureTime frame
The incidence of any respiratory adverse event (The occurrence of any of the following events is recorded, such as Laryngeal spasm, bronchospasm, deoxygenation saturation, airway obstruction, severe cough and stridor);

Secondary

MeasureTime frame
The incidence of single intraoperative or postoperative respiratory adverse event;The incidence of intraoperative replacement of laryngeal mask airway with endotracheal tube;The FLACC score of postoperative sore throat;The duration of surgery operation;The duration of airway establishment;The duration of extubation;Number of intraoperative ventilator setting adjustments;Postoperative additional analgesic administration;Supplementary oxygenation interventions after removal of endotracheal tube or laryngeal mask airway;The lowest SpO2 during emergence;Duration of postoperative cough (in days);Duration of hospitalization;Postoperative pulmonary complications (PPCs);Onset or exacerbation of upper respiratory infection symptoms;Delirium scores in the PACU;

Countries

China

Contacts

Public ContactLi Wenxian

Eye and ENT Hospital, Fudan University

liwenxian@eentanesthesia.com+86 139 1742 6838

Outcome results

None listed

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