Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization

NCT03116373 | Completed

• 1 other identifier: 29BRC17.0025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the secondary shifting of the tracheal tube when the head is moved under general anaesthesia. Two sites of fixation (the maxilla and the mandible) are tested in a prospective, double blind, randomized and crossover designed study. The study test the hypothesis that taping the tracheal tube on the mandible better prevents a secondary tube move.

Conditions

Intubation, Intratracheal

Keywords

Posture; Physiology; Head; Intubation; Intratracheal methods

Outcome Measures

Primary Outcomes (1)

• Maximal amplitude of the tracheal tube shifting

  The main outcome is the maximal amplitude of the tracheal tube shifting when the head is bended on the chest and extended in the back, controlled by bronchoscopy with each fixing technique.

  2 minutes

Secondary Outcomes (1)

• Movement of the tracheal tube from the neutral position

  2 minutes

Study Arms (2)

maxilla fixing then mandible fixing

ACTIVE COMPARATOR

The tracheal tube is first fixed on the maxilla. After the measures of the outcomes, its site of fixation is changed for the mandible for the outcome measurement in the second site of fixation.

Other: mandible fixation; Other: Maxilla fixation

mandible fixing then maxilla fixing

ACTIVE COMPARATOR

The tracheal tube is first fixed on the mandible. After the measures of the outcomes, its site of fixation is changed for the maxilla for the outcome measurement in the second site of fixation.

Other: mandible fixation; Other: Maxilla fixation

Interventions

mandible fixation OTHER

Intubation device will be fixed on mandible

mandible fixing then maxilla fixing; maxilla fixing then mandible fixing

Maxilla fixation OTHER

Intubation device will be fixed on maxilla

mandible fixing then maxilla fixing; maxilla fixing then mandible fixing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Bronchoscopy or endobronchial ultrasound
• General anaesthesia
• Tracheal intubation

You may not qualify if:

• Patient incapable of consenting or with a legal guardian or declining participation
• Forbidden or impaired cervical mobility (less than 80°)
• Mouth opening less than 35 mm
• Moustache or Beard

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest University Hospital

Brest, 29200, France

Location

Related Publications (9)

• Conrardy PA, Goodman LR, Lainge F, Singer MM. Alteration of endotracheal tube position. Flexion and extension of the neck. Crit Care Med. 1976 Jan-Feb;4(1):8-12. doi: 10.1097/00003246-197601000-00002. No abstract available.

  PMID: 1253616 RESULT

• Yap SJ, Morris RW, Pybus DA. Alterations in endotracheal tube position during general anaesthesia. Anaesth Intensive Care. 1994 Oct;22(5):586-8. doi: 10.1177/0310057X9402200515.

  PMID: 7818064 RESULT

• Hartrey R, Kestin IG. Movement of oral and nasal tracheal tubes as a result of changes in head and neck position. Anaesthesia. 1995 Aug;50(8):682-7. doi: 10.1111/j.1365-2044.1995.tb06093.x.

  PMID: 7645696 RESULT

• Sugiyama K, Yokoyama K. Displacement of the endotracheal tube caused by change of head position in pediatric anesthesia: evaluation by fiberoptic bronchoscopy. Anesth Analg. 1996 Feb;82(2):251-3. doi: 10.1097/00000539-199602000-00006.

  PMID: 8561322 RESULT

• Rost JR, Frush DP, Auten RL. Effect of neck position on endotracheal tube location in low birth weight infants. Pediatr Pulmonol. 1999 Mar;27(3):199-202. doi: 10.1002/(sici)1099-0496(199903)27:33.0.co;2-o.

  PMID: 10213259 RESULT

• Olufolabi AJ, Charlton GA, Spargo PM. Effect of head posture on tracheal tube position in children. Anaesthesia. 2004 Nov;59(11):1069-72. doi: 10.1111/j.1365-2044.2004.03963.x.

  PMID: 15479313 RESULT

• 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 RESULT

• Jordi Ritz EM, Von Ungern-Sternberg BS, Keller K, Frei FJ, Erb TO. The impact of head position on the cuff and tube tip position of preformed oral tracheal tubes in young children. Anaesthesia. 2008 Jun;63(6):604-9. doi: 10.1111/j.1365-2044.2008.05440.x.

  PMID: 18477271 RESULT

• 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 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: May 29, 2017
• Primary Completion: August 8, 2017
• Study Completion: September 30, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)