Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care

NCT03766568 | Unknown

• 1 other identifier: Sinus-Endo Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

This is a pilot study to assess the first time use of the JGG endoscope® in humans and in primary care. The JGG endoscope® is attached to a Heine® otoscope and allows to inspect and to collect samples from the middle meatus of the sinus. The JGG endoscope® is sterile packaged, for one way use and disposable.

Conditions

Acute Bacterial Sinusitis

Keywords

Rhinosinusitis; upper respiratory tract infection; antibiotic; endoscopy; Otolaryngology; primary care

Outcome Measures

Primary Outcomes (2)

• Prevalence of successful JGG endoscope® application

  The number of patients with successful visualization and sample collection from the middle meatus with the JGG endoscope®

  Baseline Day 0

• Prevalence of complications

  The number of patients with complications related to the examination with the JGG endoscope®.

  2 weeks follow-up

Secondary Outcomes (7)

• Influence of JGG endoscope® to support the decision of antibiotic prescribing

  one weeks follow-up

• Prevalence of bacterial Rhinosinusitis

  2 weeks follow-up

• Prevalence of any or deferred antibiotic prescriptions

  2 weeks follow-up

• Number of days with restrictions

  2 weeks follow-up

• Patients's acceptability of JGG endoscope®

  one week follow-up

Study Arms (1)

Diagnostic with JGG endoscope

EXPERIMENTAL

Device: JGG endoscope(R)

Interventions

JGG endoscope(R) DEVICE

The JGG endoscope(R) is attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.

Diagnostic with JGG endoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients aged ≥18 years, with acute rhinosinusitis
• Duration: worsening of symptoms after 5 days after onset of symptoms or if symptoms persist for more than 10 days, but no longer than 28 days. In addition, Criteria 1 and 2 must be fulfilled.
• Criteria 1 for acute rhinosinusitis:
• \[Nasal blockage/obstruction/congestion OR Nasal Discharge (anterior/ posterior nasal drip)\] AND \[Facial pain/ pressure OR Reduction or loss of smell\]
• Criteria 2 for acute bacterial rhinosinusitis
• Indicated by the presence of at least one of the following symptoms:
• discoloured discharge (unilateral predominance)
• severe local pain (unilateral predominance)
• fever, that is \>38°C
• elevated inflammatory markers (CRP)
• 'double sickening' whereby the patient's condition deteriorates.

You may not qualify if:

• Not being able to provide written informed consent in German (due to any mental or intellectual problem or other reasons)
• Not being available for follow-up
• Previous participation in Sinus-Endo study
• Use of antibiotic the last 4 weeks
• Known pathology or malformation of the sinuses or nasal cavity (like polyposis)
• Known pregnancy
• Allergic reactions to local anaesthetics
• Anticoagulation therapy

Sponsors & Collaborators

• Dominik Glinz: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (6)

Praxis Vogt

Liestal, Basel-Landschaft, 4410, Switzerland

RECRUITING

Hausarztpraxis Muttenz AG

Muttenz, Basel-Landschaft, 4132, Switzerland

RECRUITING

mediX toujours Pratteln

Pratteln, Basel-Landschaft, 4133, Switzerland

RECRUITING

HNO Klinik, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

mediX toujours Basel

Basel, Canton of Basel-City, 4051, Switzerland

RECRUITING

Praxis Hammer

Basel, Canton of Basel-City, 4057, Switzerland

NOT YET RECRUITING

Related Publications (1)

• Glinz D, Georg Hansen J, Trutmann C, Schaller B, Vogt J, Diermayr C, Marti A, Leitmeyer K, Doerig P, Zeller A, Welge-Luessen Lemcke A, Bucher HC. Single-use device endoscopy for the diagnosis of acute bacterial rhinosinusitis in primary care: A pilot and feasibility study. Clin Otolaryngol. 2021 Sep;46(5):1050-1056. doi: 10.1111/coa.13785. Epub 2021 May 24.

  PMID: 33866681 DERIVED

MeSH Terms

Conditions

Rhinosinusitis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Rhinitis; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Heiner C Bucher, Prof.

  CEB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Glinz, Dr. sc.

CONTACT

+41 61 328 54 02; dominik.glinz@usb.ch

Heiner C Bucher, Prof.

CONTACT

+41 61 556 5100; heiner.bucher@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective observational cohort study (single arm study)

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 6, 2018
• Study Start: December 17, 2018
• Primary Completion: May 31, 2020
• Study Completion: September 30, 2020
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

CH (6)