Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Prevalence of successful JGG endoscope® application
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Prevalence of successful JGG endoscope® application
时间窗: Baseline Day 0
The number of patients with successful visualization and sample collection from the middle meatus with the JGG endoscope®
Prevalence of complications
时间窗: 2 weeks follow-up
The number of patients with complications related to the examination with the JGG endoscope®.
次要结局
- 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)
- Prevalence of serious adverse events(2 weeks follow-up)
- Physicians' acceptability by a global usefulness rating on Likert scales(6 month)
研究者
Dominik Glinz
Principal investigator
Basel Institute for Clinical Epidemiology and Biostatistics