Awake Nasal Intubation in Laryngopharyngeal Tumors

NCT03546088 | Completed

• 1 other identifier: marchisioan
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

awake intubation; nasal fiberscope; topical anesthesia

Outcome Measures

Primary Outcomes (1)

• The duration of the procedure

  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.

  10 minutes

Secondary Outcomes (3)

• Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response

  10 minutes

• Early and late complications

  During procedure and 48 hours post-procedure

• Patient satisfaction about the procedure at 24 hours post-procedure

  24 hours

Study Arms (1)

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.

Device: fiberoptic naso-tracheal intubation; Drug: Topical anaesthesia; Drug: Light sedation

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.

awake naso-tracheal intubation

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.

awake naso-tracheal intubation

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.

awake naso-tracheal intubation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Cluj County Emergency Hospital- ENT Clinic

Cluj-Napoca, Cluj, 400006, Romania

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Ioan Florin Marchis, Md

  Iuliu Hatieganu University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Head of the Anaesthesia Dept. of ENT Clinic- Cluj Napoca

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 6, 2018
• Study Start: February 20, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 25, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

RO (1)