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

Acute Bacterial Sinusitis Clinical Trial

— Sinus-Endo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766568
• Other study ID #: Sinus-Endo Study
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2020
• Source: Basel Institute for Clinical Epidemiology and Biostatistics
• Contact: Dominik Glinz, Dr. sc.
• Phone: +41 61 328 54 02
• Email: dominik.glinz[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bacterial Sinusitis
• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	HNO Klinik, University Hospital Basel	Basel	BS
Switzerland	mediX toujours Basel	Basel	BS
Switzerland	Praxis Hammer	Basel	BS
Switzerland	Praxis Vogt	Liestal	BL
Switzerland	Hausarztpraxis Muttenz AG	Muttenz	BL
Switzerland	mediX toujours Pratteln	Pratteln	BL

Sponsors (2)

Lead Sponsor	Collaborator
Dominik Glinz	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Prevalence of complications	The number of patients with complications related to the examination with the JGG endoscope®.	2 weeks follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence of serious adverse events	The number of patients with any serious adverse event within the two weeks follow-up	2 weeks follow-up

External Links

•   Clinical Trial Registry from Switzerland