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

Pulmonary Disease Clinical Trial

— CRISPEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981264
• Other study ID #: Transcricoid EBUS RCT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 2019

Study information

• Verified date: November 2020
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Transcricoid Injection

• Spray as you go

Locations

Country	Name	City	State
India	AIIMS	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cough count	Cough count till reaching carina	At study completion approximately 12 months
Primary	Operator rated overall procedure satisfaction	Operator rated satisfaction on VAS scale	Through study completion, an average of 1 year
Secondary	Time from scope insertion to crossing the vocal cords	Time in seconds	At study completion approximately 12 months
Secondary	Overall procedure duration	Time in minutes	At study completion approximately 12 months
Secondary	Total Lignocaine dose	Total dose of lignocaine in milligrams	At study completion approximately 12 months