Xylometazoline During Nasal Flexible Bronchoscopy (VAIN)

March 8, 2019 updated by: Karan Madan, All India Institute of Medical Sciences, New Delhi

Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial

Flexible bronchoscopy is a commonly performed procedure and is usually performed transnasally. The optimal topical anesthesia regimen for bronchoscopy is investigational. Topical Vasoconstrictors like xylometazoline produce decongestion of nasal mucosa and may make insertion of bronchoscope easier. The addition of topical vasoconstrictor to lignocaine may have advantage in terms of patient comfort and for reducing local complications. Although evaluated in the settings of nasal endoscopy and nasotracheal intubation, randomized trials on the role of topical vasoconstrictors during flexible bronchoscopy are not available. The aim of this randomized trial is to study the effect of topical nasal xylometazoline administration during flexible bronchoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: Randomized double-blind placebo controlled study Study setting: Bronchoscopy room in Department of pulmonary medicine and sleep disorders at AIIMS, New Delhi Sample size: 200 patients (100 in each arm)

Inclusion criteria:

a) All adults > 18 years of age undergoing flexible bronchoscopy via nasal route

Exclusion criteria:

  1. Uncontrolled hypertension
  2. coronary artery disease

b) Pregnancy c) refusal of consent d) Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3 e) Bronchoscopy not performed by nasal route f) Bronchoscopy performed through an artificial airway

Randomisation:

Computer generated Block randomisation with block size of 10 will be used to generate list of random numbers based on which subjects will be allocated to either of the groups.

Procedure of study The operator, assistant, drug administrator and outcomes assessor will be blinded. Patients meeting eligibility criteria will be randomized to receive either study drug Xylometazoline (0.1% nasal drops) (Otrivin, Novartis) (3 drops into each nostril) or 0.9% saline (3 drops into each nostril) placebo. This will be administered as ten minutes before bronchoscopy. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril and 4 sprays of 10% lignocaine to the pharynx. Nebulized lignocaine shall not be administered. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine solution administered as "spray as you go" method. All diagnostic procedures or airway inspection procedures will be included. Patients shall undergo hemodynamic monitoring throughout the procedure. Procedures shall be performed without administration of upfront sedation and intraprocedural sedation shall be at the discretion of the operator.

Data will be recorded on a predesigned proforma. Baseline patient characteristics will be compared between the two groups. Categorical variables will be summarised by frequency (%) and chi-square test of proportion will be used to compare between the two groups.Quantitative variables will be summarised by mean±SD or median(IQR),as appropriate. Student's t-test or Wilcoxon rank sum test as appropriately be used to compare distribution of quantitative variables between the two groups. Stata statistical software will be used for data analysis.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New Delhi, India, 110029
        • AIIMS
    • New Delhi
      • Delhi, New Delhi, India, 110029
        • AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

- All adults > 18 years of age undergoing flexible bronchoscopy via nasal route

Exclusion criteria:

  • Uncontrolled hypertension
  • coronary artery disease
  • Pregnancy
  • refusal of consent
  • Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
  • Bronchoscopy not performed by nasal route
  • Bronchoscopy performed through an artificial airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xylometazoline
Patients receiving topical xylometazoline nasally during bronchoscopy
Nasal administration of Xylometazoline
Placebo Comparator: Saline placebo
Patients receiving topical saline nasally during bronchoscopy
Nasal administration of 0.9% Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
Time Frame: At study completion approximately 4 months
Visual Analogue scale
At study completion approximately 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
Time Frame: At study completion approximately 4 months
10 point scale divided into six categories
At study completion approximately 4 months
Patient rated nasal pain on procedure completion (VAS)
Time Frame: At study completion approximately 4 months
Visual Analogue scale
At study completion approximately 4 months
Operator rated nasal mucosal trauma (VAS)
Time Frame: At study completion approximately 4 months
Visual Analogue scale
At study completion approximately 4 months
Complications
Time Frame: At study completion approximately 4 months
Proportion of patients developing complications
At study completion approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karan Madan, MD, DM, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IEC AIIMS/Vasoconstrictor RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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