BronchoscopyVAINNCT03424889
Xylometazoline During Nasal Flexible Bronchoscopy
A study testing Xylometazoline and Saline in people with Bronchoscopy, run by All India Institute of Medical Sciences at 2 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Xylometazoline and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults > 18 years of age undergoing flexible bronchoscopy via nasal route
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Bronchoscopy
- Being tested
- Xylometazoline, Saline
- Keywords
- Bronchoscopy, Lignocaine, Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylometazolineDrug
Nasal administration of Xylometazoline
SalineDrug
Nasal administration of 0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| Xylometazoline | Experimental | Patients receiving topical xylometazoline nasally during bronchoscopy Receives: Drug: Xylometazoline |
| Saline placebo | Placebo comparator | Patients receiving topical saline nasally during bronchoscopy Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
Visual Analogue scale
Measured: At study completion approximately 4 months
Secondary outcomes (4)
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
10 point scale divided into six categories
Measured: At study completion approximately 4 months
Patient rated nasal pain on procedure completion (VAS)
Visual Analogue scale
Measured: At study completion approximately 4 months
Operator rated nasal mucosal trauma (VAS)
Visual Analogue scale
Measured: At study completion approximately 4 months
Complications
Proportion of patients developing complications
Measured: At study completion approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Jun 2018
- Primary completion18 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karan Madan, All India Institute of Medical Sciences
- Investigators
- Karan Madan, MD, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424889
- Sponsor's protocol ID
- IEC AIIMS/Vasoconstrictor RCT
- Acronym
- VAIN
- Status last verified
- Mar 2019
- First submitted
- 1 Feb 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33518471
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03424889
- Acronym / sponsor ID
- VAIN / IEC AIIMS/Vasoconstrictor RCT
- Conditions
- Bronchoscopy
- Keywords
- Bronchoscopy, Lignocaine, Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Xylometazoline | Experimental | Drug: XylometazolinePatients receiving topical xylometazoline nasally during bronchoscopy |
| Saline placebo | Placebo comparator | Drug: SalinePatients receiving topical saline nasally during bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults > 18 years of age undergoing flexible bronchoscopy via nasal route
Key exclusion criteria (7 listed)
- Uncontrolled hypertension
- coronary artery disease
- Pregnancy
- refusal of consent
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XylometazolineNasal administration of Xylometazoline | Drug | Xylometazoline |
| SalineNasal administration of 0.9% Saline | Drug | Saline placebo |
Primary outcome
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
Time frame: At study completion approximately 4 months
Visual Analogue scale
4 secondary outcomes
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
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
Complications
Time frame: At study completion approximately 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Derived from this study: PubMed 33518471Sryma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karan Madan, MD, DM principal investigator
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylometazoline and Saline in people with Bronchoscopy, run by All India Institute of Medical Sciences at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator rated difficulty in nasal bronchoscope negotiation (VAS) (time frame: At study completion approximately 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.