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

NCT03045094 | Completed

• 1 other identifier: 12015C1043
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Anesthesia; Tracheal Intubation

Keywords

pediatric; intubation; neck movement

Outcome Measures

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.

  10min (time that the measurement need)

Secondary Outcomes (3)

• Distance of tracheal length

  10min (time that the measurement need)

• Serious complication of unexpected displacement of the endotracheal tube: accidental extubation

  intraoperative

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

  intraoperative

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Related Publications (9)

• 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.

  PMID: 7137685 BACKGROUND

• 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.

  PMID: 9014541 BACKGROUND

• 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.

  PMID: 16176312 BACKGROUND

• 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.

  PMID: 17121553 BACKGROUND

• 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.

  PMID: 24958069 BACKGROUND

• 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.

  PMID: 3377215 BACKGROUND

• 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.

  PMID: 16464981 BACKGROUND

• 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.

  PMID: 16192505 BACKGROUND

• 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.

  PMID: 19639372 BACKGROUND

Study Officials

• SIYI YAN, MD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: March 20, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Real time access

Locations

CN (1)