CTRI/2024/07/071383已完成4 期
Use of Videolaryngoscope for Transesophageal Probe Insertion in Pediatric Patients Undergoing Cardiac Surgery
U N Mehta Institute of Cardiology and Research Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the incidence of oropharyngeal injury, which is defined as blood at the tip of TEE probe at the end of surgery and/or evidence of injury on VL examination at the end of surgery.
研究概览
简要总结
- After careful assessment and written informed consent, patients will be included into study. On arrival, a peripheral venous cannula will be inserted. Standard monitoring include, 5 lead ECG, CVP, pulse oximetry, invasive blood pressure monitoring. General anaesthesia will be induced as per institutional protocol. All patients will be intubated using conventional rigid laryngoscope with appropriately-sized endotracheal tube. After tracheal intubation, oropharyngeal secretions will be suctioned. If there would be blood staining or trauma due to intubation would be diagnosed, patient will be excluded from the study. Patients will be randomised into two groups. Group C (conventional group): TEE probe would be inserted blindly. Group VL (videolaryngoscope group): VL scope would be used for TEE probe insertion. VLScope would be inserted intraorally, and after viewing esophageal inlet, TEE probe would be advanced into esophagus under direct vision. TEE probe will removed after performing cardiac evaluation at the end of surgery and probe tip will be examined for presence or absence of blood. After TEE removal, all patients will be examined for pharyngeal injury, hematoma and sites of injury will be documented. Number of attempts for TEE probe insertion will be documented. Relationship between esophageal inlet and larynx will be documented with a photograph. Number of attempts required for TEE probe insertion and injuries in both the groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age 2-10 years weight > 5kg.
排除标准
- •Contraindications for TEE insertion Deranged coagulation parameters difficult tracheal intubation patients with sore throat, oropharyngeal infection and sore throat.
结局指标
主要结局
To study the incidence of oropharyngeal injury, which is defined as blood at the tip of TEE probe at the end of surgery and/or evidence of injury on VL examination at the end of surgery.
时间窗: After removal of TEE probe at the time of completion of surgery.
次要结局
- number of attempts required for successful TEE probe insertion & relationship between esophageal inlet & larynx.
研究者
研究点 (1)
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