- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03116373
Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization (Fix-IOT)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Brest, Frankrike, 29200
- Brest University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
Intubation device will be fixed on mandible
Intubation device will be fixed on maxilla
|
|
Aktiv komparator: 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.
|
Intubation device will be fixed on mandible
Intubation device will be fixed on maxilla
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximal amplitude of the tracheal tube shifting
Tidsram: 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.
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2 minutes
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Movement of the tracheal tube from the neutral position
Tidsram: 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.
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2 minutes
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
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Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
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Uppdateringar av studier
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Nyckelord
Andra studie-ID-nummer
- 29BRC17.0025
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