- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424889
Xylometazoline During Nasal Flexible Bronchoscopy (VAIN)
Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial
Study Overview
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:
- Uncontrolled hypertension
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Delhi, India, 110029
- AIIMS
-
-
New Delhi
-
Delhi, New Delhi, India, 110029
- AIIMS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Karan Madan, MD, DM, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEC AIIMS/Vasoconstrictor RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Bronchoscopy
-
Paion UK Ltd.Premier Research Group plcCompleted
-
Guangzhou Institute of Respiratory DiseaseCompleted
-
Instituto de Investigación Sanitaria de la Fundación...Ambu A/SCompleted
-
MaineHealthCompleted
-
Pulmonx CorporationCompleted
-
Chang Gung Memorial HospitalCompleted
-
Pusan National University HospitalUnknownBronchoscopyKorea, Republic of
-
University of OklahomaCompletedBronchoscopyUnited States
-
University Hospital, GenevaCentre Valaisan de Pneumologie, CH-3960MontanaCompleted
-
Eisai Inc.PPD; Covance; Quest Pharmaceutical ServicesTerminated
Clinical Trials on Xylometazoline
-
University of ZurichCompletedObstructive Sleep Apnea Syndrome | RhinitisSwitzerland
-
Bitop AGCompletedAcute RhinosinusitisGermany
-
Bitop AGCompletedAcute RhinosinusitisGermany
-
Oulu University HospitalUnknownBirch Pollen Allergy | Healthy Control SubjectsFinland
-
Schneider Children's Medical Center, IsraelCompleted
-
NovartisCompleted
-
Sorlandet Hospital HFRecruiting
-
Children's & Women's Health Centre of British ColumbiaCompleted
-
Lovisenberg Diakonale HospitalUnknown
-
Huro Biotech Joint Stock CompanyVietstar Biomedical ResearchCompletedRhinitis | RhinosinusitisVietnam