Xylometazoline During Nasal Flexible Bronchoscopy

NCT03424889 | Completed DMC

• 1 other identifier: IEC AIIMS/Vasoconstrictor RCT
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchoscopy

Keywords

Bronchoscopy; Lignocaine; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Operator rated difficulty in nasal bronchoscope negotiation (VAS)

  Visual Analogue scale

  At study completion approximately 4 months

Secondary Outcomes (4)

• Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion

  At study completion approximately 4 months

• Patient rated nasal pain on procedure completion (VAS)

  At study completion approximately 4 months

• Operator rated nasal mucosal trauma (VAS)

  At study completion approximately 4 months

• Complications

  At study completion approximately 4 months

Study Arms (2)

Xylometazoline

EXPERIMENTAL

Patients receiving topical xylometazoline nasally during bronchoscopy

Drug: Xylometazoline

Saline placebo

PLACEBO COMPARATOR

Patients receiving topical saline nasally during bronchoscopy

Drug: Saline

Interventions

Xylometazoline DRUG

Nasal administration of Xylometazoline

Xylometazoline

Saline DRUG

Nasal administration of 0.9% Saline

Saline placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (2)

AIIMS

Delhi, New Delhi, 110029, India

Location

AIIMS

New Delhi, 110029, India

Location

Related Publications (1)

• Sryma PB, Mittal S, Tiwari P, Mohan A, Hadda V, Guleria R, Madan K. Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized, double-blind, placebo-controlled trial. Respir Investig. 2021 May;59(3):350-355. doi: 10.1016/j.resinv.2020.12.004. Epub 2021 Jan 29.

  PMID: 33518471 DERIVED

MeSH Terms

Interventions

xylometazoline; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Karan Madan, MD, DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Concealed envelopes
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karan Madan, MD DM, Assistant Professor, Pulmonary Medicine and Sleep Disorders

Model Details: Randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: June 1, 2018
• Primary Completion: December 18, 2018
• Study Completion: January 31, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)