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Completed

NCT Number: NCT03045094

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

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.

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Key information

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distance of trachea carina (TC) to endotracheal tube (ETT) tip

    Time frame: 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 outcomes

  1. Distance of tracheal length

    Time frame: 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.

  2. Serious complication of unexpected displacement of the endotracheal tube: accidental extubation

    Time frame: intraoperative

    When the operator put the child's neck into extension position, accidental extubation may occur, which can lead to hypoxia and asphyxia.

  3. Serious complication of unexpected displacement of the endotracheal tube: endobronchial intubation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Neck Flexion and Extension Implicate the Tracheal Tube-tip Displacement in Children Undergoing Head and Neck Surgeries

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2017
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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