Clinical trial · Interventional
Awake Nasal Intubation in Laryngopharyngeal Tumors
Awake Nasal Intubation With a Flexible Nasolaryngoscope in Patients With Laryngeal, Oro and Hypo-pharynx Tumours With Midazolam-fentanyl-droperidol Sedation Protocol- Technique and Patient Satisfaction
- 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)
This study evaluates the efficiency of awake naso-tracheal intubation and patient satisfaction when using a small diameter flexible nasolaryngoscope together with topical anaesthesia and light sedation with a combination of benzodiazepine and fentanyl. The selected patients will have difficult airway access because of obstructing oro- and hypo-pharynx tumours.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Airway Management | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fiberoptic naso-tracheal intubation | Device | — | UNRESOLVED |
| Light sedation | Drug | — | UNRESOLVED |
| Topical anaesthesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- awake naso-tracheal intubation
- description
- The patients with obstructive oro and hypo-pharynx tumours will have their airway secured through awake fiberoptic naso-tracheal intubation with light sedation and topical anaesthesia with lidocaine. The sedation will be provided in small boluses until the desired level will be achieved not exceeding 0.05 mg/kg of midazolam and 3 mcg/kg fentanyl. The dose of lidocaine will be to a maximum of 7 mg/kg. The reinforced intubating tube will be lubricated with lidocaine gel.
- interventionNames
- Device: fiberoptic naso-tracheal intubation
- Drug: Topical anaesthesia
- Drug: Light sedation
Primary outcomes (1)
- measure
- The duration of the procedure
- timeFrame
- 10 minutes
- description
- The duration of the successful naso-tracheal intubation, starting from the passage of the intubating tube through one of the nostrils until the endotracheal intubation confirmation by free bag movement and capnography.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access. Exclusion Criteria: * Patients who refuse the procedure, with bleeding disorders, acute respiratory failure manifested by stridor or the impossibility of nasal passage are excluded from the study.
References
Publications (1)
- DERIVEDBreazu CM, Marchis IF, Negrut MF, Crihan M, Alexa AL, Blebea CM. The Flexible Rhino-Laryngoscope for Awake Nasotracheal Intubation. J Vis Exp. 2024 Aug 2;(210). doi: 10.3791/66875. PMID 39158288