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

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ClinicalTrials.gov Identifier: NCT03045094
Recruitment Status : Unknown
Verified January 2018 by Yan Siyi, Beijing Tsinghua Chang Gung Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yan Siyi, 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.

Condition or disease
Pediatric Anesthesia Tracheal Intubation

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neck Flexion and Extension Implicate the Tracheal Tube-tip Displacement in Children Undergoing Head and Neck Surgeries
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : March 1, 2018



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045094


Contacts
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Contact: SIYI YAN, MD 86-10-56119610 yansiyi03@hotmail.com
Contact: HUAN ZHANG, MD 86-10-56119358 zhanghuan60175@163.com

Locations
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China, Beijing
Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital Recruiting
Beijing, Beijing, China, 102218
Contact: SIYI YAN, MD    86-10-56119610    yansiyi03@hotmail.com   
Contact: HUAN ZHANG, MD    86-10-56119358    zhanghuan60175@163.com   
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
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Principal Investigator: SIYI YAN, MD Beijing Tsinghua Chang Gung Hospital

Publications:

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Responsible Party: Yan Siyi, Attending Doctor, Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT03045094    
Other Study ID Numbers: 12015C1043
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After recruiting, upload the distance of trachea carina(TC) to endotracheal tube (ETT) tip and the distance of tracheal length of each volunteer.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Real time access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Siyi, Beijing Tsinghua Chang Gung Hospital:
pediatric
intubation
neck movement