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

A

All India Institute Of Medical Science (AIIMS)

Status

Completed

Conditions

Pulmonary Disease

Treatments

Drug: Transcricoid injection
Drug: Spray as you go

Study type

Interventional

Funder types

Other

Identifiers

NCT02981277
Transcricoid RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Transcricoid
Active Comparator group
Description:
Lignocaine delivery using transcricoid injection
Treatment:
Drug: Transcricoid injection
Spray as You go
Active Comparator group
Description:
Lignocaine delivery using spray as you go method
Treatment:
Drug: Spray as you go

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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