Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA

Study Overview
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Brief Summary
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Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

Detailed Description
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For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to transcricoid injection or spray as you go lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the use of transcricoid injection in one group. During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure. Post procedure, patients will record the pain experienced while undergoing the procedure on the VAS scale.

Official Title
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Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial

Conditions
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Pulmonary Disease

Intervention / Treatment
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* Drug: Transcricoid Injection
* Drug: Spray as you go


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for EBUS TBNA Age > 18 years Exclusion Criteria: Refusal of consent Known documented hypersensitivity to lignocaine Procedure performed under general anaesthesia Pregnancy Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3 Bronchoscopy done through endotracheal or tracheostomy tube Midline neck mass or thyroid enlargement making the identification of cricothyroid membrane difficult' Patients with central airway obstruction Patients with active ongoing hemoptysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcricoid<br>Lignocaine delivery using transcricoid injection | Drug: Transcricoid Injection<br> <br> * Other names: Lignocaine delivered through the cricothyroid membrane;|
| Active Comparator: Spray as You go<br>Lignocaine delivery using spray as you go method | Drug: Spray as you go<br> <br> * Other names: Lignocaine delivered through the bronchoscope working channel.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cough count | Cough count till reaching carina | At study completion approximately 12 months | 
| Operator rated overall procedure satisfaction | Operator rated satisfaction on VAS scale | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from scope insertion to crossing the vocal cords | Time in seconds | At study completion approximately 12 months | 
| Overall procedure duration | Time in minutes | At study completion approximately 12 months | 
| Total Lignocaine dose | Total dose of lignocaine in milligrams | At study completion approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Lignocaine, Endobronchial Ultrasound