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

NCT ID: NCT03766568

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2020-09-30

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.

Detailed Description

Acute rhinosinusitis is one of the most common reasons for consultations and antibiotic prescriptions in primary care although the condition is primarily of viral origin. The main reason for antibiotic overuse in acute rhinosinusitis is the lack of diagnostic tests of sufficient accuracy to confirm or rule out the diagnosis of acute bacterial rhinosinusitis (ABRS).

The gold standard for the diagnosis of ABRS is a bacterial culture from sinus maxillary puncture. This procedure is painful, prone to complications and only done in selected patients by oto-rhino-laryngology (ORL) specialists or for research purposes. Therefore, endoscopy of the middle meatus and collection of diagnostic material from the ostium draining the sinus is the diagnostic method of choice for ABRS and routinely used by ORL specialists in house and elsewhere. In patients with clinical symptoms of sufficient severity and duration (typically 5-10 days) for ABRS, endoscopy has a sensitivity of 85.7% (95% confidence interval, 56.2-97.5), specificity of 90.6% (73.8-97.5), positive predictive value of 80% (51.4-94.7), negative predictive value of 93.5% (77.2-98.9) for culture proven ABRS when compared with cultures gained from sinus puncture. Because of high upfront costs and logistical reason (disinfection) endoscopy is not used in general practice or internal medicine.

Dr. Jens G. Hansen has developed the disposable JGG endoscope® (JGG stands for the surnames of the inventor and his wife) which can be 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.

In a pilot study the investigators would like to test the JGG endoscope® in 60 patients with suspected acute bacterial rhinosinusitis in the ORL unit of the University Hospital Basel and selected general practices that collaborate with the Centre for Primary Health Care of the University of Basel.

Objectives:

1. To assess the feasibility of visualization and sample collection from the middle meatus with the JGG endoscope® in patients with clinically diagnosed acute bacterial rhinosinusitis in Swiss primary care setting

2. to investigate whether the JGG endoscope® supports the decision of antibiotic prescribing

3. to assess patients' and physicians' acceptability of the examination with the JGG endoscope®

4. to investigate the prevalence of culture proven acute bacterial rhinosinusitis from samples of the middle meatus by the JGG endoscope® in patients with clinically diagnosed acute rhinosinusitis

5. to investigate the number of patients with acute rhinosinusitis diagnosed by the JGG endoscope® with any and/or deferred antibiotic prescriptions

6. to investigate the days with restrictions and symptoms in patients with acute rhinosinusitis with positive and negative bacterial cultures diagnosed by the JGG endoscope®

7. to investigate any serious adverse event related to the JGG endoscope®.

Design Prospective observational cohort study (single arm study)

Conditions

Acute Bacterial Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic with JGG endoscope

Group Type: EXPERIMENTAL

JGG endoscope(R)

Intervention Type: 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.

Interventions

JGG endoscope(R)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Dominik Glinz

OTHER

Sponsor Role: lead

Responsible Party

Dominik Glinz

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Heiner C Bucher, Prof.

Role: PRINCIPAL_INVESTIGATOR

CEB

Locations

Praxis Vogt

Liestal, Basel-Landschaft, Switzerland

Site Status: RECRUITING

Hausarztpraxis Muttenz AG

Muttenz, Basel-Landschaft, Switzerland

Site Status: RECRUITING

mediX toujours Pratteln

Pratteln, Basel-Landschaft, Switzerland

Site Status: RECRUITING

HNO Klinik, University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

mediX toujours Basel

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Praxis Hammer

Basel, Canton of Basel-City, Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Central Contacts

Dominik Glinz, Dr. sc.

Role: CONTACT

dominik.glinz@usb.ch

+41 61 328 54 02

Heiner C Bucher, Prof.

Role: CONTACT

heiner.bucher@usb.ch

+41 61 556 5100

Facility Contacts

Jürg Vogt, MD

Role: primary

+619310080

Bernhard Schaller, MD

Role: primary

+41614612828

Andreas Marti, MD

Role: primary

+41 61 825 90 90

Katharina Leitmeyer, MD

Role: primary

+41 61 328 71 08

Caroline Trutmann, MD

Role: primary

+41 61 500 11 00

Claus Diermayr, MD

Role: primary

+41 61 692 88 11

References

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.

Reference Type: DERIVED

PMID: 33866681 (View on PubMed)

Other Identifiers

Sinus-Endo Study

Identifier Type: -

Identifier Source: org_study_id