An interventional study of JGG endoscope(R) in Acute Bacterial Sinusitis, sponsored by Dominik Glinz. Status unknown at 6 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Dominik Glinz · Not applicable, Interventional, and Diagnostic
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.
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:
Design Prospective observational cohort study (single arm study)
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →This is the only study on the registry with Dominik Glinz as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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.
Prevalence of successful JGG endoscope® application
The number of patients with successful visualization and sample collection from the middle meatus with the JGG endoscope®
Time frame: Baseline Day 0
Prevalence of complications
The number of patients with complications related to the examination with the JGG endoscope®.
Time frame: 2 weeks follow-up
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.
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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.
Time frame: 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.
Time frame: 6 month
Prevalence of serious adverse events
The number of patients with any serious adverse event within the two weeks follow-up
Time frame: 2 weeks follow-up
Plan to share: Undecided
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