Phase 4
Completed N=30
Endotracheal Tube Holder and Bite Guard Research
Surgery · Anesthesia
Source: ClinicalTrials.gov NCT02347488 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in ETT Position — 3.4; 0.3 centimeters — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study aims to test the effectiveness of a novel combined endotracheal tube holder and bite guard when compared with the current standard of care, tape and an oral airway.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ETT Position |
3.4; 0.3 | <0.001 sig |
| SECONDARY Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device |
2 | — |
| SECONDARY Clinically Significant Movement |
29; 1 | — |
| SECONDARY Potentially High Extubation Risk |
9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- General anesthesia requiring oral endotracheal intubation in the prone position for the duration of surgery (head secured in a foam head holder, horseshoe frame, or Mayfield pins).
- General anesthesia for neurosurgery requiring oral endotracheal intubation, supine or slight lateral bump position for the duration of surgery. (Special emphasis will be placed on including patients who will undergo motor evoked potentials, and thus will not be paralyzed during the surgery).
- General anesthesia requiring oral endotracheal intubation with a left sided double-lumen endotracheal tube for lung isolation, lateral position for the duration of surgery.
Exclusion Criteria
- Dentition issues (loose teeth, missing teeth)
- Temporomandibular joint disease
- Maxillofacial abnormalities (deformities of the jaw, lips, tongue)
- Surgical procedures involving the teeth, lips, jaw
- History of asthma or bronchospasm
- Immunosuppression.
Data sourced from ClinicalTrials.gov (NCT02347488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.