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

Not Applicable

Completed

• Conditions: Intubation, Intratracheal
• Interventions: Other: mandible fixation; Other: Maxilla fixation

• Registration Number: NCT03116373
• Lead Sponsor: University Hospital, Brest

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-17
• Study Start: 2017-05-29
• Primary Completion: 2017-08-08
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
maxilla fixing then mandible fixing	mandible fixation	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.
maxilla fixing then mandible fixing	Maxilla fixation	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.
mandible fixing then maxilla fixing	mandible fixation	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.
mandible fixing then maxilla fixing	Maxilla fixation	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.

Primary Outcome Measures

Name	Time	Method
Maximal amplitude of the tracheal tube shifting	2 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Movement of the tracheal tube from the neutral position	2 minutes	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.

Trial Locations

Locations (1)

Brest University Hospital; 🇫🇷 Brest, France