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

NCT02981277 | Completed DMC

• 1 other identifier: Transcricoid RCT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease

Keywords

Bronchoscopy; Lignocaine

Outcome Measures

Primary Outcomes (1)

• Cough count from bronchoscope introduction till reaching the carina

  At study completion approximately 12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Transcricoid

ACTIVE COMPARATOR

Lignocaine delivery using transcricoid injection

Drug: Transcricoid injection

Spray as You go

ACTIVE COMPARATOR

Lignocaine delivery using spray as you go method

Drug: Spray as you go

Interventions

Transcricoid injection DRUG

Lignocaine delivery using Transcricoid Injection

Transcricoid

Spray as you go DRUG

Lignocaine delivery using Spray as you go method

Spray as You go

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Randeep Guleria, MD, DM

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

IN (1)