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

Primary Purpose

Nasopharyngeal Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nasopharyngeal Diseases focused on measuring hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Hypertonic sea water

    Lidocaine

    Xylometazoline

    0.9% Sodium chloride

    Arm Description

    The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.

    The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.

    The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.

    The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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).
    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.

    Full Information

    First Posted
    December 23, 2019
    Last Updated
    December 30, 2019
    Sponsor
    Selcuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04214938
    Brief Title
    Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    May 1, 2018 (Actual)
    Study Completion Date
    January 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Selcuk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Diseases
    Keywords
    hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A Double Blind, Randomized, Controlled Trial
    Masking
    ParticipantInvestigator
    Masking Description
    The caregiver administering the nasal spray, the subject, and the otolaryngologist carrying out nasendoscopy were all uninformed as to the type of spray employed.
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypertonic sea water
    Arm Type
    Active Comparator
    Arm Description
    The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.
    Arm Title
    Lidocaine
    Arm Type
    Active Comparator
    Arm Description
    The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.
    Arm Title
    Xylometazoline
    Arm Type
    Active Comparator
    Arm Description
    The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.
    Arm Title
    0.9% Sodium chloride
    Arm Type
    Placebo Comparator
    Arm Description
    The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.
    Intervention Type
    Other
    Intervention Name(s)
    Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
    Other Intervention Name(s)
    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)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Quality of view, ease of procedure
    Description
    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)
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Post-op pain
    Description
    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).
    Time Frame
    2 years
    Title
    Post-op discomfort
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ozkan Onal, Professor
    Organizational Affiliation
    Selcuk University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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