VAIN: Xylometazoline During Nasal Flexible Bronchoscopy

Sponsor

All India Institute of Medical Sciences, New Delhi (Other)

Overall Status

Completed

CT.gov ID

NCT03424889

Collaborator

(none)

148

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchoscopy	Drug: Xylometazoline Drug: Saline	N/A

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:

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

Exclusion criteria:

Uncontrolled hypertension
coronary artery disease

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 Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double blind, placebo controlledRandomized, double blind, placebo controlled

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Concealed envelopes

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Dec 18, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Xylometazoline

Patients receiving topical xylometazoline nasally during bronchoscopy

Drug: Xylometazoline

Nasal administration of Xylometazoline

Placebo Comparator: Saline placebo

Patients receiving topical saline nasally during bronchoscopy

Drug: Saline

Nasal administration of 0.9% Saline

Outcome Measures

Primary Outcome Measures

Operator rated difficulty in nasal bronchoscope negotiation (VAS) [At study completion approximately 4 months]
Visual Analogue scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIIMS	Delhi	New Delhi	India	110029
2	AIIMS	New Delhi		India	110029

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karan Madan, Karan Madan, MD DM, Assistant Professor, Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT03424889

Other Study ID Numbers:

IEC AIIMS/Vasoconstrictor RCT

First Posted:

Feb 7, 2018

Last Update Posted:

Mar 11, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karan Madan, Karan Madan, MD DM, Assistant Professor, Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi

Bronchoscopy

Lignocaine

Anaesthesia

Additional relevant MeSH terms:

Xylometazoline

Study Results

No Results Posted as of Mar 11, 2019