Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization
NCT ID: NCT03116373
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2017-05-29
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study test the hypothesis that taping the tracheal tube on the mandible better prevents a secondary tube move.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
maxilla fixing then mandible fixing
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 fixation
Intubation device will be fixed on mandible
Maxilla fixation
Intubation device will be fixed on maxilla
mandible fixing then maxilla fixing
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 fixation
Intubation device will be fixed on mandible
Maxilla fixation
Intubation device will be fixed on maxilla
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mandible fixation
Intubation device will be fixed on mandible
Maxilla fixation
Intubation device will be fixed on maxilla
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Bronchoscopy or endobronchial ultrasound
* General anaesthesia
* Tracheal intubation
Exclusion Criteria
* Forbidden or impaired cervical mobility (less than 80°)
* Mouth opening less than 35 mm
* Moustache or Beard
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Brest
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brest University Hospital
Brest, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
29BRC17.0025
Identifier Type: -
Identifier Source: org_study_id