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

Transcricoid Injection Versus Spray as You go Method for Local Anaesthesia During Flexible Bronchoscopy: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: 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 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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • All India Institute of medical Sciences

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cough count from bronchoscope introduction till reaching the carina	At study completion approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from scope insertion to crossing the vocal cords	At study completion approximately 12 months
Overall procedure duration	At study completion approximately 12 months
Total Lignocaine dose	At study completion approximately 12 months
Operator rated overall procedure satisfaction	Through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

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 26, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lignocaine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Transcricoid RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED