- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981264
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA (CRISPEN)
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 Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Delhi, India, 110029
- AIIMS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Other Names:
|
Active Comparator: Spray as You go
Lignocaine delivery using spray as you go method
|
Other Names:
|
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
Investigators
- Study Chair: Randeep Guleria, MD, DM, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- Transcricoid EBUS RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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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