Nasopharyngeal DiseasesPhase 4NCT04214938
Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures
A Phase 4 study testing Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization in people with Nasopharyngeal Diseases, run by Selcuk University.
Trial summary
Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Diseases
- What is being tested?
- Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Jan 2019
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who undergone diagnostic nasal endoscopy between 2015- 2017
Who cannot join
- Had experienced nasal endoscopy before
- Pregnant
- Allergic to either xylometazoline or lidocaine
- Asthma
- Cardiovascular disease
- Rhinitis
- Severe septal deviation
About this study
Official title: Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures: A Double Blind, Randomized, Controlled Trial Comparing the Efficacy of Intranasal Hypertonic Saline, Xylometazoline, Lidocaine, and Isotonic Saline
Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.
Read the detailed description
NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.
- Conditions
- Nasopharyngeal Diseases
- Being tested
- Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
- Keywords
- hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort
- Medical subject headings
- Nasopharyngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationOther
Also called intranasal hypertonic sea water (Ancient Secrets, USA), intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden), intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK), intranasal isotonic saline (Deva, Istanbul, TR)
Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic sea water | Active comparator | The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure. Receives: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization |
| Lidocaine | Active comparator | The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure. Receives: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization |
| Xylometazoline | Active comparator | The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure. Receives: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization |
| 0.9% Sodium chloride | Placebo comparator | The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure. Receives: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of view, ease of procedure
The primary outcome was to evaluate clinicians' field of the view according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, the endoscopist was asked to indicate the degree of quality of view, ease of procedure on a VAS (1: impossible to pass the endoscope, 100: excellent field of view)
Measured: 2 years
Secondary outcomes (2)
Post-op pain
The secondary outcome was to evaluate the patients' pain after the naso-endoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, subjects were asked to indicate their degree of pain on a VAS (1: no pain, 100: unbearable pain).
Measured: 2 years
Post-op discomfort
The secondary outcome was to evaluate the patients' discomfort after the nasoendoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after spraying each bottle, subjects were asked to indicate their degree of discomfort on a visual analogue scale (VAS) (1: no discomfort, 100: utmost discomfort). For each spray, one independent scores were obtained from each subject.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Feb 2016
- Primary completion1 May 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal DiseasesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double Blind, Randomized, Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Onal, Selcuk University
- Investigators
- Ozkan Onal, Professor, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214938
- Sponsor's protocol ID
- 15.01.2015
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures: A Double Blind, Randomized, Controlled Trial Comparing the Efficacy of Intranasal Hypertonic Saline, Xylometazoline, Lidocaine, and Isotonic Saline
- ClinicalTrials.gov ID
- NCT04214938
- Acronym / sponsor ID
- 15.01.2015
- Conditions
- Nasopharyngeal Diseases
- Keywords
- hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 2 Jan 2020 (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.
Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.
Detailed description
NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- A Double Blind, Randomized, Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Hypertonic sea water | Active comparator | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationThe patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure. |
| Lidocaine | Active comparator | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationThe patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure. |
| Xylometazoline | Active comparator | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationThe patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure. |
| 0.9% Sodium chloride | Placebo comparator | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationThe patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who undergone diagnostic nasal endoscopy between 2015- 2017
Key exclusion criteria (7 listed)
- Had experienced nasal endoscopy before
- Pregnant
- Allergic to either xylometazoline or lidocaine
- Asthma
- Cardiovascular disease
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 |
|---|---|---|
| Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomizationAlso: intranasal hypertonic sea water (Ancient Secrets, USA), intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden), intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK), intranasal isotonic saline (Deva, Istanbul, TR)Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort. | Other | 0.9% Sodium chloride, Hypertonic sea water, Lidocaine, Xylometazoline |
Primary outcome
Quality of view, ease of procedure
Time frame: 2 years
The primary outcome was to evaluate clinicians' field of the view according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, the endoscopist was asked to indicate the degree of quality of view, ease of procedure on a VAS (1: impossible to pass the endoscope, 100: excellent field of view)
2 secondary outcomes
Post-op pain
Time frame: 2 years
Post-op discomfort
Time frame: 2 years
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 2 Jan 2020.
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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.
Ozkan Onal, Professor principal investigator
Selcuk University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization in people with Nasopharyngeal Diseases, run by Selcuk University.
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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of view, ease of procedure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.