Awake Nasal Intubation in Laryngopharyngeal Tumors

NCT ID: NCT03546088

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2018-12-25

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.

Conditions

Airway Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

awake naso-tracheal intubation

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.

Group Type: EXPERIMENTAL

fiberoptic naso-tracheal intubation

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

fiberoptic naso-tracheal intubation

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.

Intervention Type: DEVICE

Topical anaesthesia

Topical anaesthesia with lidocaine will be provided through nebulisation and instillation. The intubating tube will be lubricated with a gel containing lidocaine.

Intervention Type: DRUG

Light sedation

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Marchis Ioan Florin

Principal Investigator- Head of the Anaesthesia Dept. of ENT Clinic- Cluj Napoca

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioan Florin Marchis, Md

Role: PRINCIPAL_INVESTIGATOR

Iuliu Hatieganu University of Medicine and Pharmacy

Locations

Cluj County Emergency Hospital- ENT Clinic

Cluj-Napoca, Cluj, Romania

Countries

Romania

Other Identifiers

marchisioan

Identifier Type: -

Identifier Source: org_study_id