Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Hypoxia İncidence
研究概览
简要总结
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.
详细描述
ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition.
In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
Single (Participant) closed envelope technique
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status 1-2
- •Elective Procedures
- •Body mass index 18.5 - 35 kg/m2
排除标准
- •High risk of pulmonary aspiration
- •Pregnancy
- •Anesthesic drug allergies
- •Difficult airway or facial deformities
- •Height <155 cm
- •Alcohol or narcotic drug usage
- •Restrictive or obstructive pulmonary diseases
- •Hepatic cardiac or renal failure
- •Neurologic or cognitive deficiencies.
- •Previous cervical surgery or cervical radiotherapy
- •Previous esophagus surgery
- •Psychotic problems
研究组 & 干预措施
Wei Nasal Jet Tube Group (Group W)
After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
干预措施: Wei Nasal Jet Tube (Device)
Gastro-Laryngeal Tube Group (Group G)
After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients.
干预措施: Gastro Laryngeal Tube (Device)
结局指标
主要结局
Hypoxia İncidence
时间窗: Intra-operative; after device insertion
Hypoxia is defined as SpO2 \<92% at any time.
Endoscopist Satisfaction Analysis: Score
时间窗: Intra-operative, during the procedure
It is determined by the endoscopist according to the endoscopy satisfaction scale according to the maneuverability of the duodenoscope and the number of insertion attempts. (0-10 Points) The endocopist satisfaction score is scored on a minimum score of 0 and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction.
次要结局
- Presence of sore throat(One hour after extubation)
- Incidence of hypercapnia(Intra-operative; after device insertion)
- Blood staining on the device(Immediately after removing the supraglottic airway device)
研究者
Harun UYSAL
Principal Investigator
Bezmialem Vakif University