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

Intubation, Intratracheal Clinical Trial

— Fix-IOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116373
• Other study ID #: 29BRC17.0025
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: October 18, 2017
• Start date: May 29, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tracheal intubation is the only technique to ensure airway protection, meaning preventing aspiration, and providing mechanical ventilation during general anesthesia (GA). This is an extremely frequent procedure. After intubation, the head of the patient is often moved as the patient is positioned for the surgical procedure (ENT, thoracic and abdominal surgeries, lateral or prone positioning…). This may even happen several times during the same procedure. It is well demonstrated that these head movements are responsible for secondary shifting of the tube (1-9). This can cause accidental extubation or selective bronchial intubation.

The anesthesiologist secures the tube with tape to prevent secondary displacement of the tracheal tube. The two most common sites to tape the tube on patient's face are the maxilla, because it is a fixed spot on the face, and the mandible, because its mobility coming from the temporomandibular joint may allow a better interlock with the larynx.

There is no study and no recommendation about the best site of tape. Both techniques are commonly used, depending on the anesthesiologist's preference.

Investigators designed a, controlled study in Brest university hospital to compare two groups by cross-over intervention (one group "maxilla fixing then mandible fixing" and one group "mandible fixing then maxilla fixing").

The population is composed of adult patients undergoing bronchoscopy or endobronchial ultrasound under GA and after tracheal intubation. The bronchoscope allows a permanent control of the tracheal tube's position, and the possibility of shifting it without compromising patient security, which is not possible in other daily surgical procedure.

Statisticien estimate that the total number of patients to include is 36. In order to avoid a sequence effect, the order of the fixing technique will be randomized. Every patient will be its own control as there is a cross over-design.

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.

The anesthesiologist investigator will use the first fixing site according to the patient's randomization group. Then, he will display an opaque cover around the tracheal tube, so that the operator, who will measure the tube displacements, will stay blind. As the intervention is performed under GA, the patient will also be blind. The same procedure will be performed after the second fixing site is used, before the end of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Bronchoscopy or endobronchial ultrasound

• General anaesthesia

• Tracheal intubation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Other:
• mandible fixation
Intubation device will be fixed on mandible
• Maxilla fixation
Intubation device will be fixed on maxilla

Locations

Country	Name	City	State
France	Brest University Hospital	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Olufolabi AJ, Charlton GA, Spargo PM. Effect of head posture on tracheal tube position in children. Anaesthesia. 2004 Nov;59(11):1069-72. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Feb 7. Revie — View Citation

Yap SJ, Morris RW, Pybus DA. Alterations in endotracheal tube position during general anaesthesia. Anaesth Intensive Care. 1994 Oct;22(5):586-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Movement of the tracheal tube from the neutral position	For each fixation site (maxillary or mandibular), the tracheal tube displacement from the neutral position is measured when the head is bended on the chest and when it is extended in the back.	2 minutes