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Observation of the sealing effect and safety of a new type of endotracheal tube in pediatric patients

Observation of the sealing effect and safety of a new type of endotracheal tube in pediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094897
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

None listed

Interventions

New type of endotracheal tube group (Group A):Group A patients underwent endotracheal intubation with a new type of endotracheal tube under visual laryngoscopy After entering the operating room, elect
Ordinary cuff tracheal tube group (Group B):Group B patients underwent intubation through a regular balloon endotracheal tube under visual laryngoscopy After entering the operating room, electrocardio

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: (1) 2 years old to 8 years old ; (2) Patient classified as American Society of Anesthesiology (ASA) grade ?~II ; (3) Children planning to undergo elective oral endotracheal intubation for general anesthesia during surgery; (4) Non-airway surgery

Exclusion criteria

Exclusion criteria: (1) The family members of the patient refused to participate in the study; (2) Surgery time exceeding 4 hours; (3) Upper respiratory tract infection before and/or after surgery; (4) Pulmonary diseases (pneumonia, asthma, etc.); (5) Children at risk of reflux aspiration; (6) Children with suspected difficult airways

Design outcomes

Primary

MeasureTime frame
Inflation capacity of cuff (ml);Encapsulation pressure (cmH2O);Sealed pressure (cmH2O);

Secondary

MeasureTime frame
General information includes age, gender, body mass index, and surgical duration;Incidence of wheezing, laryngeal spasms, mucosal bleeding during tracheal intubation and/or extubation;Incidence of difficulty in vocalization after surgery;vital signs;

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