Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care (Sinus-Endo)

Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care: A Pilot and Feasibility Study

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.

Study Overview

• Status: Unknown
• Conditions: Acute Bacterial Sinusitis
• Intervention / Treatment: Device: JGG endoscope(R)

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)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BL
    • Liestal, BL, Switzerland, 4410
      • Recruiting
      • Praxis Vogt
      • Contact: Jürg Vogt, MD; Phone Number: +619310080
    • Muttenz, BL, Switzerland, 4132
      • Recruiting
      • Hausarztpraxis Muttenz AG
      • Contact: Bernhard Schaller, MD; Phone Number: +41614612828
    • Pratteln, BL, Switzerland, 4133
      • Recruiting
      • mediX toujours Pratteln
      • Contact: Andreas Marti, MD; Phone Number: +41 61 825 90 90
  • BS
    • Basel, BS, Switzerland, 4031
      • Recruiting
      • HNO Klinik, University Hospital Basel
      • Contact: Katharina Leitmeyer, MD; Phone Number: +41 61 328 71 08
    • Basel, BS, Switzerland, 4051
      • Recruiting
      • mediX toujours Basel
      • Contact: Caroline Trutmann, MD; Phone Number: +41 61 500 11 00
    • Basel, BS, Switzerland, 4057
      • Not yet recruiting
      • Praxis Hammer
      • Contact: Claus Diermayr, MD; Phone Number: +41 61 692 88 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic with JGG endoscope

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of JGG endoscope® to support the decision of antibiotic prescribing	After each examination with the JGG endoscope, each physician will report on a Likert scale with five categories how the physician would judge usefulness of the device for decision to prescribe antibiotics.(The examination with the JGG endoscope(R) supported my decision whether to prescribe antibiotics or not; possible answers 1: don't agree, 2: partially don't agree, 3: neutral, 4: partially agree, 5: agree). The findings will be presented descriptively.	one weeks follow-up
Prevalence of bacterial Rhinosinusitis	The number of patient with culture proven acute bacterial rhinosinusitis from samples of the middle meatus diagnosed by the JGG endoscope®	2 weeks follow-up
Prevalence of any or deferred antibiotic prescriptions	The number of patients with any or deferred antibiotic prescriptions in patients with acute rhinosinusitis diagnosed by the JGG endoscope®	2 weeks follow-up
Number of days with restrictions	The mean days with restrictions and symptoms from acute rhinosinusitis at Day 14 in patients with positive and negative cultures as diagnosed with the JGG endoscope®	2 weeks follow-up
Patients's acceptability of JGG endoscope®	The patients' acceptability of the device will be assessed on Likert scale (If I would suffer again from an akute sinusitis, I would again agree being investigated with the JGG endoscope(R); possible answers 1: don't agree, 2: partially don't agree, 3: don't know, 4: partially agree, 5: agree). The findings will be presented descriptively.	one week follow-up
Physicians' acceptability by a global usefulness rating on Likert scales	The physicians' acceptability will be evaluated by a global usefulness rating on Likert scales with five categories after recruitment completion (The ratio of additional effort due to the JGG endoscope(R) and the newly gained information is good, possible answers 1: don't agree, 2: partially don't agree, 3: neutral, 4: partially agree, 5: agree). The findings will be presented descriptively.	6 month
Prevalence of serious adverse events	The number of patients with any serious adverse event within the two weeks follow-up	2 weeks follow-up

Collaborators and Investigators

• Sponsor: Dominik Glinz
• Collaborators: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Heiner C Bucher, Prof., CEB

Publications and helpful links

General Publications

• 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.

Helpful Links

• Clinical Trial Registry from Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: primary care; antibiotic; endoscopy; Otolaryngology; upper respiratory tract infection; Rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: Sinus-Endo Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No