Insertion of a Transoesophageal Echocardiography Probe Using McGRATH Video Laryngoscope in Cardiac Surgery Patients: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of pharyngeal mucosal injury
研究概览
简要总结
This randomized, parallel-group clinical trial compares McGRATH video laryngoscope-assisted versus Macintosh laryngoscope-assisted transoesophageal echocardiography (TEE) probe insertion in adult elective cardiac surgery patients. The primary aim is to compare incidence of pharyngeal mucosal injury during TEE probe insertion.
详细描述
Transoesophageal echocardiography (TEE) is essential in cardiac anesthesia but TEE probe insertion can cause oropharyngeal mucosal injury and, rarely, esophageal perforation. In this prospective randomized study, adults (≥18 years, ASA II-III) undergoing elective cardiac surgery requiring intraoperative TEE will be randomized 1:1 to TEE probe insertion assisted by either the McGRATH MAC video laryngoscope (M group) or a conventional Macintosh laryngoscope (C group). After induction and tracheal intubation, TEE probe insertion will be attempted with the head in neutral position; the esophageal inlet visibility, number of attempts, total insertion time (seconds), intraoperative vital signs during insertion, and anesthesiologist satisfaction will be recorded. A blinded observer will assess pharyngeal mucosal injury (laceration and/or hematoma) immediately after probe removal. Sample size: 100 (50 per arm). An interim safety analysis will occur after 50 patients; a DSMB will review safety.
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
- Single (Outcomes Assessor)
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 (male or female) aged ≥ 18 years
- •ASA physical status II or III
- •Scheduled for elective cardiac surgery under general anesthesia requiring intraoperative transoesophageal echocardiography
- •Able to provide written informed consent
排除标准
- •Dysphagia or sore throat
- •Oropharyngeal infection
- •Cervical spine pathology
研究组 & 干预措施
McGRATH group
TEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position.
干预措施: McGRATH group (Device)
Macintoch group
TEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position.
干预措施: Macintosh group (Device)
结局指标
主要结局
Incidence of pharyngeal mucosal injury
时间窗: Immediately after TEE probe removal (intraoperatively)
Presence of laceration and/or hematoma in the posterior pharyngeal wall, postcricoid area, lateral/medial walls of the piriform sinuses, or the esophageal inlet as observed by a blinded observer after removal of the TEE probe.
次要结局
- Visibility of the oesophageal inlet(During TEE probe insertion (first insertion attempt, intraoperatively))
- Duration of TEE probe insertion (seconds)(During the intraoperative TEE probe insertion procedure)
- Number of insertion attempts(During the intraoperative TEE probe insertion procedure)
研究者
Hassan Mohamed Ali
Professor of anaesthesia
Cairo University