Clinical trial · Interventional
Comparison Between a Standard Tube and the Ultra-thin Tritube for Intubation of the Trachea and for Maintaining Access to the Trachea After Anaesthesia, in Patients With an Expected Difficult Direct Laryngoscopy
Sammenligning Mellem Standard Tube og Den Ultra-tynde Tritube® Til Intubation, og Til Opretholdelse af Adgang Til Trachea Efter anæstesi, Hos Patienter Med Forventet Vanskelig Direkte Laryngoskopi
NCT03653039CI-TRIAL-00074532TritubecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
| Oral Neoplasm | Oral Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pharynx Cancer | Malignant Pharyngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard enditracheal tube | Device | — | UNRESOLVED |
| Tritube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tritube
- interventionNames
- Device: Tritube
- type
- ACTIVE_COMPARATOR
- label
- Standard endotracheal tube
- interventionNames
- Device: Standard enditracheal tube
Primary outcomes (1)
- measure
- Rate of Excellent intubation conditions
- timeFrame
- 2 hours
- description
- Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
Secondary outcomes (18)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat * planned for oral intubation with video-laryngoscopy * with risk factors for difficult direct laryngoscopy Exclusion Criteria: * Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough) * Patients planned for awake intubation * Patients where mask-ventilation is judged to could become impossible * Patients where access to the cricothyroid membrane is judged to be difficult or impossible * Patients in ASA (american Society of Anaesthesiologists) physical classification status \>3 * Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration * Patients with stridor * Patients with hypoxemia (Saturation \< 90 % in room air) * Operation duration planned to \> 2.5 hours * Patients with the need for a nerve-stimulation-tube during surgery
References
Publications (3)
- BACKGROUNDFuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x. PMID 17635389
- BACKGROUNDKristensen MS, de Wolf MWP, Rasmussen LS. Ventilation via the 2.4 mm internal diameter Tritube(R) with cuff - new possibilities in airway management. Acta Anaesthesiol Scand. 2017 Jul;61(6):580-589. doi: 10.1111/aas.12894. Epub 2017 Apr 23. PMID 28436022
- BACKGROUNDStrom C, Barnung S, Kristensen MS, Bottger M, Tvede MF, Rasmussen LS. Tracheal intubation in patients with anticipated difficult airway using Boedeker intubation forceps and McGrath videolaryngoscope. Acta Anaesthesiol Scand. 2015 Oct;59(9):1154-60. doi: 10.1111/aas.12543. Epub 2015 May 16. PMID 25982220