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Comparison of the effect of the new type of steerable intubation introducer and the common stylet in tracheal intubation for children under general anesthesia

Comparison of the efficacy of a novel steerable intubation introducer (Total Control Introducer, TCI) versus a standard stylet for tracheal intubation in pediatric patients under general anesthesia: A randomized, double-blind, single-center, non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111241
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

None listed

Interventions

Ordinary guide core assembly(Group C):After the induction process is completed and the drug reaches its peak concentration, an endotracheal tube with an ordinary guide wire is inserted into the trache
New type of rotatable catheter insertion device(Group T):After the induction process is completed and the drug reaches its peak concentration, the tracheal tube + TCI is used for tracheal intubation u

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Pediatric patients between 3 and 12 years old; 2.ASA grade I ~ II; 3 Children scheduled for general anesthesia via oral tracheal intubation;

Exclusion criteria

Exclusion criteria: 1.Unable to communicate. The child has neurological or mental disorders such as autism, developmental delay, etc. 2. Children with persistent adenoid or tonsillar inflammation, systemic or local infections. 3. Acute upper respiratory tract infection. 4. Pharyngeal infection, hematoma, abscess, etc. 5. Carotid aneurysm. 6. Children with congenital diseases. Such as congenital diseases affecting brain development, congenital heart disease, etc. 7. Have drug or food allergies, are allergic individuals, etc. 8. Other conditions deemed uncomfortable in research.

Design outcomes

Primary

MeasureTime frame
Duration of intubation;

Secondary

MeasureTime frame
Times of intubation;Changes in blood pressure, heart rate and pulse during the operation;Postoperative oropharyngeal symptoms;Postoperative oral mucosal injury;Whether the teeth are loose or not;Postoperative pain score;

Countries

China

Contacts

Public ContactShangguan Wangning

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

sgwning@163.com+86 135 8763 7891

Outcome results

None listed

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