---
title: Awake Nasal Intubation in Laryngopharyngeal Tumors
nct_id: NCT03546088
overall_status: COMPLETED
phase: NA
sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
study_type: INTERVENTIONAL
primary_condition: Airway Management
countries: Romania
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03546088.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03546088"
ct_last_update_post_date: 2020-07-14
last_seen_at: "2026-05-12T07:01:20.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Awake Nasal Intubation in Laryngopharyngeal Tumors

**Official Title:** 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

**NCT ID:** [NCT03546088](https://clinicaltrials.gov/study/NCT03546088)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Iuliu Hatieganu University of Medicine and Pharmacy
- **Conditions:** Airway Management
- **Start Date:** 2018-02-20
- **Completion Date:** 2018-12-25
- **CT.gov Last Update:** 2020-07-14

## Brief Summary

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.

## Detailed Description

Awake naso-tracheal fiberoptic intubation is an established method of securing a difficult airway. The patient's comfort and optimum intubation conditions are paramount for success. The study proposes to analyse a series of patients with obstructive pharyngo-laryngeal pathology, following the degree of satisfaction, reliability of the procedure and any incidents or complications.

Awake intubation could be the safest way to control difficult airway as the patient maintains spontaneous respiration and intact reflexes. Main concerns for the success of this procedure should be a good technique, a calm and cooperative patient and good preparation with careful topical anaesthesia and appropriate sedation. The tool used in this study will be a flexible nasolaryngoscope of 2.9 mm diameter and 300 mm working length which might offer an advantage over lengthier fiberscopes in matter of manoeuvrability and patient comfort. Prior intubation the patients will have an upper airway fiberscopic exam from nostrils to tracheae with the same tool.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **awake naso-tracheal intubation** (EXPERIMENTAL) — 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.

## Interventions

- **fiberoptic naso-tracheal intubation** (DEVICE) — The trachea will be intubated under direct fiberoptic view after a fiberoptic upper airway examination. The flexible nasolaryngoscope will be armed with an intubating tube and passed inside tracheal lumen trough one of the nostrils.
- **Topical anaesthesia** (DRUG) — Topical anaesthesia with lidocaine will be provided through nebulisation and instillation. The intubating tube will be lubricated with a gel containing lidocaine.
- **Light sedation** (DRUG) — The patient will be sedated with a combination of midazolam, fentanyl administered intravenously in small boluses until the desired level of sedation is achieved as expressed of The Observer's Assessment of Alertness/Sedation Scale (OAA/S) of 4 or 5.

## Primary Outcomes

- **The duration of the procedure** _(time frame: 10 minutes)_ — 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

- **Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response** _(time frame: 10 minutes)_
- **Early and late complications** _(time frame: During procedure and 48 hours post-procedure)_
- **Patient satisfaction about the procedure at 24 hours post-procedure** _(time frame: 24 hours)_

## Locations (1)

- Cluj County Emergency Hospital- ENT Clinic, Cluj-Napoca, Cluj, Romania

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cluj county emergency hospital- ent clinic|cluj-napoca|cluj|romania` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03546088*  
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