Awake Fiber Optic Intubation (AFOI) and Laryngeal Nervous Block

Awake Fiber Optic Intubation (AFOI) in Patients With Stenosis of the Upper Airway: Utility of the Laryngeal Nervous Block

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.

Study Overview

• Status: Unknown
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Drug: superior laryngeal nerve block with lidocaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00100
    • Recruiting
    • Sapienza University of Rome
    • Contact: Francesco Alessandri, MD; Phone Number: 3880594460; Email: francesco.alessandri@uniroma1.it
    • Contact: Edoardo Piervincenti, MD; Phone Number: 3472259741; Email: edoardo.piervincenti@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-SLNB; performed a superior laryngeal nerve block with lidocaine	Drug: superior laryngeal nerve block with lidocaine; SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane; Other Names: L-SLNB
Placebo Comparator: S-SLNB; performed a superior laryngeal nerve block with saline	Drug: superior laryngeal nerve block with lidocaine; SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane; Other Names: L-SLNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discomfort	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	up to 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypoxemia	number of desaturation events	up to 10 minutes
time required to intubate	minutes to intubation	up to 10 minutes
intraprocedural hemodynamic stability	reducing blood pressure > 30%	up to 10 minutes

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Anticipated): July 24, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: AFOISUA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No