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

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Transcricoid Injection
Spray as you go
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease focused on measuring Bronchoscopy, Lignocaine, Endobronchial Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AIIMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transcricoid

Spray as You go

Arm Description

Lignocaine delivery using transcricoid injection

Lignocaine delivery using spray as you go method

Outcomes

Primary Outcome Measures

Overall cough count
Cough count till reaching carina
Operator rated overall procedure satisfaction
Operator rated satisfaction on VAS scale

Secondary Outcome Measures

Time from scope insertion to crossing the vocal cords
Time in seconds
Overall procedure duration
Time in minutes
Total Lignocaine dose
Total dose of lignocaine in milligrams

Full Information

First Posted
December 1, 2016
Last Updated
November 25, 2020
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT02981264
Brief Title
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
Bronchoscopy, Lignocaine, Endobronchial Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcricoid
Arm Type
Active Comparator
Arm Description
Lignocaine delivery using transcricoid injection
Arm Title
Spray as You go
Arm Type
Active Comparator
Arm Description
Lignocaine delivery using spray as you go method
Intervention Type
Drug
Intervention Name(s)
Transcricoid Injection
Other Intervention Name(s)
Lignocaine delivered through the cricothyroid membrane
Intervention Type
Drug
Intervention Name(s)
Spray as you go
Other Intervention Name(s)
Lignocaine delivered through the bronchoscope working channel.
Primary Outcome Measure Information:
Title
Overall cough count
Description
Cough count till reaching carina
Time Frame
At study completion approximately 12 months
Title
Operator rated overall procedure satisfaction
Description
Operator rated satisfaction on VAS scale
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Time from scope insertion to crossing the vocal cords
Description
Time in seconds
Time Frame
At study completion approximately 12 months
Title
Overall procedure duration
Description
Time in minutes
Time Frame
At study completion approximately 12 months
Title
Total Lignocaine dose
Description
Total dose of lignocaine in milligrams
Time Frame
At study completion approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randeep Guleria, MD, DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
AIIMS
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33942745
Citation
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.
Results Reference
derived

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

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