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

Pulmonary Disease Clinical Trial

— CRISP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981277
• Other study ID #: Transcricoid RCT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: March 2018

Study information

• Verified date: November 2018
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Drug:
• Transcricoid injection
Lignocaine delivery using Transcricoid Injection
• Spray as you go
Lignocaine delivery using Spray as you go method

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough count from bronchoscope introduction till reaching the carina		At study completion approximately 12 months
Secondary	Time from scope insertion to crossing the vocal cords		At study completion approximately 12 months
Secondary	Overall procedure duration		At study completion approximately 12 months
Secondary	Total Lignocaine dose		At study completion approximately 12 months
Secondary	Operator rated overall procedure satisfaction		Through study completion, an average of 1 year