Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nasopharyngeal Diseases

Intervention / Treatment
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* Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who undergone diagnostic nasal endoscopy between 2015- 2017 Exclusion Criteria: Had experienced nasal endoscopy before Pregnant Allergic to either xylometazoline or lidocaine Asthma Cardiovascular disease Rhinitis Severe septal deviation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Double Blind, Randomized, Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypertonic sea water<br>The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure. | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization<br>* 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.<br>* Other names: intranasal isotonic saline (Deva, Istanbul, TR);|
| Active Comparator: Lidocaine<br>The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure. | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization<br>* 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.<br>* Other names: intranasal isotonic saline (Deva, Istanbul, TR);|
| Active Comparator: Xylometazoline<br>The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure. | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization<br>* 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.<br>* Other names: intranasal isotonic saline (Deva, Istanbul, TR);|
| Placebo Comparator: 0.9% Sodium chloride<br>The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure. | Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization<br>* 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.<br>* Other names: intranasal isotonic saline (Deva, Istanbul, TR);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort