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

November 25, 2020 updated by: Karan Madan, All India Institute of Medical Sciences, New Delhi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110029
        • AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcricoid
Lignocaine delivery using transcricoid injection
Drug: Transcricoid Injection
Other Names:
  • Lignocaine delivered through the cricothyroid membrane
Active Comparator: Spray as You go
Lignocaine delivery using spray as you go method
Drug: Spray as you go
Other Names:
  • Lignocaine delivered through the bronchoscope working channel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cough count
Time Frame: At study completion approximately 12 months
Cough count till reaching carina
At study completion approximately 12 months
Operator rated overall procedure satisfaction
Time Frame: Through study completion, an average of 1 year
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 Frame: At study completion approximately 12 months
Time in seconds
At study completion approximately 12 months
Overall procedure duration
Time Frame: At study completion approximately 12 months
Time in minutes
At study completion approximately 12 months
Total Lignocaine dose
Time Frame: At study completion approximately 12 months
Total dose of lignocaine in milligrams
At study completion approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Study Chair: Randeep Guleria, MD, DM, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transcricoid EBUS RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data on demographics and outcomes shall be available on reasonable request

IPD Sharing Time Frame

For two years since the study completion

IPD Sharing Access Criteria

Available on reasonable request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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