Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT03424889 |
Date of registration:
|
01/02/2018 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Xylometazoline During Nasal Flexible Bronchoscopy
VAIN |
Scientific title:
|
Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial |
Date of first enrolment:
|
June 1, 2018 |
Target sample size:
|
148 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT03424889 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
India
| | | | | | | |
Contacts
|
Name:
|
Karan Madan, MD, DM |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
All India Institute of Medical Sciences, New Delhi |
| | |
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Bronchoscopy
|
Intervention(s)
|
Drug: Saline
|
Drug: Xylometazoline
|
Primary Outcome(s)
|
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
[Time Frame: At study completion approximately 4 months]
|
Secondary Outcome(s)
|
Complications
[Time Frame: At study completion approximately 4 months]
|
Patient rated nasal pain on procedure completion (VAS)
[Time Frame: At study completion approximately 4 months]
|
Operator rated nasal mucosal trauma (VAS)
[Time Frame: At study completion approximately 4 months]
|
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
[Time Frame: At study completion approximately 4 months]
|
Secondary ID(s)
|
IEC AIIMS/Vasoconstrictor RCT
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|