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

NCT02981264 | Completed DMC

• 1 other identifier: Transcricoid EBUS RCT
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease

Keywords

Bronchoscopy; Lignocaine; Endobronchial Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time from scope insertion to crossing the vocal cords

  At study completion approximately 12 months

• Overall procedure duration

  At study completion approximately 12 months

• Total Lignocaine dose

  At study completion approximately 12 months

Study Arms (2)

Transcricoid

ACTIVE COMPARATOR

Lignocaine delivery using transcricoid injection

Drug: Transcricoid Injection

Spray as You go

ACTIVE COMPARATOR

Lignocaine delivery using spray as you go method

Drug: Spray as you go

Interventions

Transcricoid Injection DRUG

Also known as: Lignocaine delivered through the cricothyroid membrane

Transcricoid

Spray as you go DRUG

Also known as: Lignocaine delivered through the bronchoscope working channel.

Spray as You go

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for EBUS TBNA
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

AIIMS

New Delhi, 110029, India

Location

Related Publications (1)

• Mittal S, Gupta N, Iyer H, Biswal SK, Tiwari P, Hadda V, Mohan A, Guleria R, Madan K. The cricothyroid versus Spray-As-You-Go method for topical anesthesia during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): The CRISPEN randomized clinical trial. Lung India. 2021 May-Jun;38(3):223-228. doi: 10.4103/lungindia.lungindia_801_20.

  PMID: 33942745 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Randeep Guleria, MD, DM

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: For two years since the study completion
• Access Criteria: Available on reasonable request

Locations

IN (1)