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

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ClinicalTrials.gov Identifier: NCT02981264
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pulmonary Disease Drug: Transcricoid Injection Drug: Spray as you go

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Transcricoid
Lignocaine delivery using transcricoid injection
Drug: Transcricoid Injection
Active Comparator: Spray as You go
Lignocaine delivery using spray as you go method
Drug: Spray as you go


Outcome Measures

Primary Outcome Measures :
  1. Overall cough count [ Time Frame: At study completion approximately 12 months ]

Secondary Outcome Measures :
  1. Time from scope insertion to crossing the vocal cords [ Time Frame: At study completion approximately 12 months ]
  2. Overall procedure duration [ Time Frame: At study completion approximately 12 months ]
  3. Total Lignocaine dose [ Time Frame: At study completion approximately 12 months ]
  4. Operator rated overall procedure satisfaction [ Time Frame: Through study completion, an average of 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981264


Contacts
Contact: Karan Madan, MD, DM drkaranmadan@gmail.com

Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Chair: Randeep Guleria, MD, DM All India Institute of Medical Sciences, New Delhi
More Information

Responsible Party: Karan Madan, Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02981264     History of Changes
Other Study ID Numbers: Transcricoid EBUS RCT
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Karan Madan, All India Institute of Medical Sciences, New Delhi:
Bronchoscopy
Lignocaine
Endobronchial Ultrasound

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action