Comparison Between an Anterior Rhinoscopic Scoring Scale With the Sniff Test to Predict Nasal Insertability Before Transnasal Endoscopy: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- The primary outcome measures were tolerability profiles on a validated visual analogue scale
研究概览
简要总结
A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet there is no objective method to select an appropriate meatus insertion site (MIS) where tolerance and epistaxis rate can be improved.
The investigators hypothesize that that an objective anterior rhinoscopy (to be more specific, the investigators term it "anterior meatoscopy") method might be more effective than the subjective breathing-in method (sniff test) to select the appropriate meatus insertion site, thus reducing nasal bleeding and nasal discomfort.
The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events during nasal anesthesia and UT-EGD.
The investigators will perform a prospective randomized-controlled trial to compare patient tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral hospital in Taiwan.
详细描述
Transnasal esophago-gastro-duodenoscopy (UT-EGD) offers physicians and patients a number of advantages compared with conventional peroral EGD (P-EGD) and has become increasingly popular in clinical practice over the past several years. However, insertion failure varying from 2.3% to 62.7% due to tight nasal vault have been reported. Dumortire reported 17.9 % of patient refused UT-EGD due to nasal pain and epistaxis remains to be a common side effect. Therefore a well performed nasal anesthesia has been regarded as the most important step for UT-EGD.
The concept of endoscopic guidance is actually an application of anterior rhinoscopy to select the most patent meatus for nasal anesthesia and endoscopic insertion. The scope should be placed in the side of the nasal cavity that is most patent. Therefore, it is reasonable that a nasal examination is performed prior to UT-EGD to determine the less obstructed side.
In fact, anterior rhinoscopy is a common outpatient procedure by otolaryngologists and is performed with an otoscope. Instead, we use a transnasal endoscope to select the most patent meatus and thus we first introduce the concept of anterior "meatus-copy", which is different from "meatoscopy" for the urinary meatus.
The conventional sniff nasal patency test is an inspection of nasal passability by asking a patient to compare the breathing-in air flow in either side of the nose. This is a self-selected and subjective method of choosing just the right or left nostril for transnasal endoscopy.
Nasal septum and nasal turbinates, especially the inferior turbinates, are erectile tissues in the nose, fluctuate greatly in size depending on physiological changes (e.g. body temperature and exercise) and response to inflammation. Often, the sensation of a blocked nose is subjective. The otolaryngologist may find a perfectly patent airway and yet the patient will insist that his nose is clogged up. Therefore, an objective method to evaluate nasal patency would help to avoid a narrowed meatus, thereby reducing nasal pain and epistaxis during nasal anesthesia and transnasal endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligible for this study.
排除标准
- •Patients who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. Patients who are allergic to an anesthetic agent and who have uncontrolled hypertension or coronary artery disease are not recruited. Those who are uncooperative and unable to answer questions are also excluded.
结局指标
主要结局
The primary outcome measures were tolerability profiles on a validated visual analogue scale
时间窗: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
The primary outcome measures were tolerability profiles on a validated visual analogue scale as previously described and difficulty in inserting the transnasal endoscope through the selected meatus based on a Likert scale. The scale contained 5 points of difficulty: minimal, slight, moderate, substantial, and extreme. Facing a 5-point VAS card (1 = minimal discomfort to 5 = severe discomfort), all patients gave realtime feedback by speaking or pointing out their scorings for the following: (1) pain during anesthesia, (2) pain during nasal insertions, and (3) pain during exsertion, and they answered immediately after UT-EGD for (4) overall tolerance.
次要结局
- Secondary outcome measure evaluates the side effects of transnasal endoscopy(Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes))
研究者
Chi-Tan Hu
Chief, Division of Gastroenterology, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital