Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery

Completed

• Conditions: Pediatric Anesthesia; Tracheal Intubation

• Registration Number: NCT03045094
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

This study evaluates the effect of head and neck movement in children on endotracheal tube (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be measured using flexible fiberoptic bronchoscope.

Detailed Description

In clinical application, especially in head-and-neck surgeries, the operators often change the position of children's head-neck for easy operating. Flexing the head resulted in the ETT moving towards the carina, and extension resulted in the tube being displaced in the opposite direction. Head and neck movement change the length of trachea as well: extending the head resulted in the extension of trachea, while flexing resulted in the opposite. Serious complications following from head and neck movement, such as accidental extubation and endobronchial intubation, threat children's life.

In pediatric anesthesia, insertion depth (cm) of orotracheal intubation equals to age/2+12, according to classic intubation formulae. The ETT will be put in the depth calculated by the classic formulae under general anesthesia. The distance of ETT-tip displacement and the length change of trachea will be measured as the head and neck placed as follows: fully extended, neutral position, or fully flexed. These three head and neck positions imitate the head-neck movement during those head-and-neck surgeries.

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Study Start: 2017-03-20
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• subject has elective head-and-neck surgery schedule
• subject will have orotracheal intubation under general anesthesia

Exclusion Criteria

• subject has malformations of the trachea or bronchus on chest X-ray
• subject has spinal deformity
• subject has difficulties in neck flexion or extension
• subject has neck pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance of trachea carina (TC) to endotracheal tube (ETT) tip	10min (time that the measurement need)	Measure the distance between trachea carina to the tip of ETT in three different neck-head positions: fully flexion, neutral positon and fully extension.

Secondary Outcome Measures

Name	Time	Method
Distance of tracheal length	10min (time that the measurement need)	Tracheal length equals the distance between trachea carina (TC) to posterior vocal commissure. Measure Tracheal length in three different neck-head positions: fully flexion, neutral positon and fully extension.
Serious complication of unexpected displacement of the endotracheal tube: accidental extubation	intraoperative	When the operator put the child's neck into extension position, accidental extubation may occur, which can lead to hypoxia and asphyxia.
Serious complication of unexpected displacement of the endotracheal tube: endobronchial intubation.	intraoperative	When the operator put the child's neck into flexion position, accidental endobronchial intubation may occur, which can lead to one-lung ventilation and pulmonary edema.

Trial Locations

Locations (1)

Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China