Clinical trial NCT03045094: Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery
Official title: Neck Flexion and Extension Implicate the Tracheal Tube-tip Displacement in Children Undergoing Head and Neck Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Anesthesia
Tracheal Intubation
Keywords: pediatric
intubation
neck movement
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 172
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who schedul to undergo elective head-and-neck surgeries under general anesthesia with orotracheal intubation will be enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distance of trachea carina (TC) to endotracheal tube (ETT) tip
timeFrame: 10min (time that the measurement need)
Secondary outcomes:
measure: Distance of tracheal length
timeFrame: 10min (time that the measurement need)
measure: Serious complication of unexpected displacement of the endotracheal tube: accidental extubation
timeFrame: intraoperative
measure: Serious complication of unexpected displacement of the endotracheal tube: endobronchial intubation.
timeFrame: intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: SIYI YAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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