Xylometazoline During Nasal Flexible Bronchoscopy

Bronchoscopy Clinical Trial

— VAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424889
• Other study ID #: IEC AIIMS/Vasoconstrictor RCT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 31, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Drug:
• Xylometazoline
Nasal administration of Xylometazoline
• Saline
Nasal administration of 0.9% Saline

Locations

Country	Name	City	State
India	AIIMS	Delhi	New Delhi
India	AIIMS	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	Operator rated difficulty in nasal bronchoscope negotiation (VAS)	Visual Analogue scale	At study completion approximately 4 months
Secondary	Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion	10 point scale divided into six categories	At study completion approximately 4 months
Secondary	Patient rated nasal pain on procedure completion (VAS)	Visual Analogue scale	At study completion approximately 4 months
Secondary	Operator rated nasal mucosal trauma (VAS)	Visual Analogue scale	At study completion approximately 4 months
Secondary	Complications	Proportion of patients developing complications	At study completion approximately 4 months