Awake Fiber Optic Intubation (AFOI) and Laryngeal Nervous Block

NCT ID: NCT03586323

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2018-08-01

Brief Summary

Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Superior laryngeal nerve block (SLNB) could be an alternative technique useful to reduce risks and to improve patient comfort. Aim of this study is to assess the procedural comfort of the SLNB during AFOI, in a population of patients suffering from severe airways obstruction undergoing pharyngeal-laryngeal surgery. 40 patients will be randomized in two groups(20 for each group) and will be treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. In group A will be associated the SLNB; placebo will be administered in group B.

Detailed Description

Patients will be randomized in two groups: group A: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue, intercricoid block and SLNB; group B: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. After the first measurement of vital parameters (T0), patients will received a continuous intravenous infusion of remifentanil at a rate ranged between 0.05 and 0.15 mcg/kg/min, reached by titration of a conscious sedation plane corresponding to the 0/-1 stage of the RASS scale. In all patients of both groups topical anesthesia of the oropharynx mucosa will be performed through 10 puffs of 10% lidocaine spray at the back of the tongue and at the base of the palatopharyngeal and palatoglossal arch. In Group A SLNB will be performed by administering 4 ml of 1.5% lidocaine below the thyroid membrane, which is palpated in addition to the intercricoid block by translaringeal puncture and 4 ml of lidocaine 1,5%. In group B intercricoid block will be performed by translaringeal puncture and 4 ml of 1.5% lidocaine. Group B will receive placebo instead of the regional block. After regional anesthesia, the patient will be placed on the operating table with the head in a neutral position. The vital parameters and the level of sedation reached (T1) will be registered. If SpO2 will be less than 96%, the patient will be pre-oxygenated with FiO2 100%. AFOI procedure will be performed using a 4 mm Olympus LF-2 bronchoscope and spiral tracheal tubes (internal diameter of between 5-6 mm) will be used. Discomfort during AFOI will be evaluated through the Fiber Optic Intubation Comfort Score. During AFOI procedure, unstructured airway maneuvers (neck's hyperextension, jaw subluxation, and pulling the tongue manually) will be evaluated. Hypoxemia, aspiration of secretions and time to perform intubation will be reported.

After intubation, a new evaluation of the vital parameters will be performed (T2) and patients will undergo to a total intravenous general anesthesia in accordance with the current international protocols. The primary endpoint will be to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score > 1. Secondary endpoint will be incidence of hypoxemia, time required to intubate, intraprocedural hemodynamic stability, airway obstruction score, need to aspirate secretions during AFOI, Tracheal Tube Tolerance Score.

Conditions

Airway Complication of Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L-SLNB

performed a superior laryngeal nerve block with lidocaine

Group Type: EXPERIMENTAL

superior laryngeal nerve block with lidocaine

Intervention Type: DRUG

SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane

S-SLNB

performed a superior laryngeal nerve block with saline

Group Type: PLACEBO_COMPARATOR

superior laryngeal nerve block with lidocaine

Intervention Type: DRUG

SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane

Interventions

superior laryngeal nerve block with lidocaine

SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane

Intervention Type: DRUG

Other Intervention Names

L-SLNB

Eligibility Criteria

Inclusion Criteria

• aged >18 years
• undergoing elective AFOI for upper airway obstruction

Exclusion Criteria

• patients with respiratory tirage and cornage
• Arnè multifactorial scale < 11

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

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Alessandri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Alessandri, MD

Role: CONTACT

francesco.alessandri@uniroma1.it

3880594460

Edoardo Piervincenzi, MD

Role: CONTACT

edoardo.piervincenzi@gmail.com

3472259741

Facility Contacts

Francesco Alessandri, MD

Role: primary

francesco.alessandri@uniroma1.it

3880594460

Edoardo Piervincenti, MD

Role: backup

edoardo.piervincenti@gmail.com

3472259741

Other Identifiers

AFOISUA

Identifier Type: -

Identifier Source: org_study_id