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Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy (CRISP)

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

Eligibility Criteria

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

Inclusion Criteria:

  • Indication for diagnostic or therapeutic flexible bronchoscopy
  • Age > 18 years
  • Hemodynamic stability (defined as systolic BP >100 mm Hg and, <180 mm Hg).

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

  • All India Institute of Medical Sciences

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

Cough count from bronchoscope introduction till reaching the carina

Secondary Outcome Measures

Time from scope insertion to crossing the vocal cords
Overall procedure duration
Total Lignocaine dose
Operator rated overall procedure satisfaction

Full Information

First Posted
December 1, 2016
Last Updated
November 23, 2018
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT02981277
Brief Title
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy
Acronym
CRISP
Official Title
Transcricoid Injection Versus Spray as You go Method for Local Anaesthesia During Flexible Bronchoscopy: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (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
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours. Topical lignocaine is administered during bronchoscopy 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 bronchoscopy. 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 and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to transcricoid or spray as you go group. Prior to the bronchoscopy 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 initial route of lignocaine delivery. During the procedure, 1.5 ml aliquots of 2% 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 instilled transtracheally along with two baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2% 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 2 VAS charts to mark the severity of cough and overall procedure satisfaction. Cough count shall be noted.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (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
Intervention Description
Lignocaine delivery using Transcricoid Injection
Intervention Type
Drug
Intervention Name(s)
Spray as you go
Intervention Description
Lignocaine delivery using Spray as you go method
Primary Outcome Measure Information:
Title
Cough count from bronchoscope introduction till reaching the carina
Time Frame
At study completion approximately 12 months
Secondary Outcome Measure Information:
Title
Time from scope insertion to crossing the vocal cords
Time Frame
At study completion approximately 12 months
Title
Overall procedure duration
Time Frame
At study completion approximately 12 months
Title
Total Lignocaine dose
Time Frame
At study completion approximately 12 months
Title
Operator rated overall procedure satisfaction
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for diagnostic or therapeutic flexible bronchoscopy Age > 18 years Hemodynamic stability (defined as systolic BP >100 mm Hg and, <180 mm Hg). 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
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy

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