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CompletedNCT03045094Updated Jul 9, 2020

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

An observational study in Pediatric Anesthesia and Tracheal Intubation, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-07-09.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
172
Ages
2 Years to 14 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Pediatric Anesthesia
  • Tracheal Intubation

Keywords

  • pediatric
  • intubation
  • neck movement
03

In context

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
172 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Measure the distance between trachea carina to the tip of ETT in three different neck-head positions: fully flexion, neutral positon and fully extension.

    Time frame: 10min (time that the measurement need)

Secondary outcomes

  1. Distance of tracheal length

    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.

    Time frame: 10min (time that the measurement need)

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

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

    Time frame: intraoperative

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

    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.

    Time frame: intraoperative

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Study locations

1 site
  • Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital
    Beijing, Beijing 102218, China
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References and documents

Publications

  • Dronen S, Chadwick O, Nowak R. Endotracheal tip position in the arrested patient. Ann Emerg Med. 1982 Feb;11(2):116-7. doi: 10.1016/s0196-0644(82)80328-4. No abstract available. PubMed 7137685 ↗
  • McCoy EP, Russell WJ, Webb RK. Accidental bronchial intubation. An analysis of AIMS incident reports from 1988 to 1994 inclusive. Anaesthesia. 1997 Jan;52(1):24-31. doi: 10.1111/j.1365-2044.1997.007-az007.x. PubMed 9014541 ↗
  • Mariano ER, Ramamoorthy C, Chu LF, Chen M, Hammer GB. A comparison of three methods for estimating appropriate tracheal tube depth in children. Paediatr Anaesth. 2005 Oct;15(10):846-51. doi: 10.1111/j.1460-9592.2005.01577.x. PubMed 16176312 ↗
  • Lau N, Playfor SD, Rashid A, Dhanarass M. New formulae for predicting tracheal tube length. Paediatr Anaesth. 2006 Dec;16(12):1238-43. doi: 10.1111/j.1460-9592.2006.01982.x. PubMed 17121553 ↗
  • Gamble JJ, McKay WP, Wang AF, Yip KA, O'Brien JM, Plewes CE. Three-finger tracheal palpation to guide endotracheal tube depth in children. Paediatr Anaesth. 2014 Oct;24(10):1050-5. doi: 10.1111/pan.12452. Epub 2014 Jun 23. PubMed 24958069 ↗
  • Bloch EC, Ossey K, Ginsberg B. Tracheal intubation in children: a new method for assuring correct depth of tube placement. Anesth Analg. 1988 Jun;67(6):590-2. No abstract available. PubMed 3377215 ↗
  • Weiss M, Knirsch W, Kretschmar O, Dullenkopf A, Tomaske M, Balmer C, Stutz K, Gerber AC, Berger F. Tracheal tube-tip displacement in children during head-neck movement--a radiological assessment. Br J Anaesth. 2006 Apr;96(4):486-91. doi: 10.1093/bja/ael014. Epub 2006 Feb 7. PubMed 16464981 ↗
  • Jin-Hee K, Ro YJ, Seong-Won M, Chong-Soo K, Seong-Deok K, Lee JH, Jae-Hyon B. Elongation of the trachea during neck extension in children: implications of the safety of endotracheal tubes. Anesth Analg. 2005 Oct;101(4):974-977. doi: 10.1213/01.ane.0000169330.92707.1e. PubMed 16192505 ↗
  • Kim JT, Kim HJ, Ahn W, Kim HS, Bahk JH, Lee SC, Kim CS, Kim SD. Head rotation, flexion, and extension alter endotracheal tube position in adults and children. Can J Anaesth. 2009 Oct;56(10):751-6. doi: 10.1007/s12630-009-9158-y. Epub 2009 Jul 29. PubMed 19639372 ↗

Individual participant data

Plan to share: Yes — After recruiting, upload the distance of trachea carina(TC) to endotracheal tube (ETT) tip and the distance of tracheal length of each volunteer.

Supporting information: Study protocol, Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03045094
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Yan Siyi (Attending Doctor, Beijing Tsinghua Chang Gung Hospital) — Principal investigator
First posted
Feb 7, 2017
Start date
Mar 20, 2017
Primary completion
Sep 30, 2018
Completion
Dec 31, 2018
Last update
Jul 9, 2020

Study contacts

SIYI YAN, MD
principal investigator · Beijing Tsinghua Chang Gung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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