Awake Nasal Intubation in Laryngopharyngeal Tumors

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Completed

Conditions: Airway Management

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03546088

marchisioan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

awake naso-tracheal intubation

Experimental group

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.

Treatment:

Device: fiberoptic naso-tracheal intubation

Drug: Topical anaesthesia

Drug: Light sedation