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临床试验/NCT05420428
NCT05420428已完成不适用

Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery: a Pilot Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
hypopharyngeal mean peak pressure

研究概览

简要总结

We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. We expected that the patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

详细描述

Background: More and more older patients required to receive orthopedic surgery recently. The intubation or supraglottic airway device are required to maintain airway during general anesthesia. Previous studies only reported the subjective swallowing discomfort feeling, however, the objective data was limited. The high-resolution impedance manometry could detect the swallowing muscle power changes with multiple pressure sensors and impedance channels.

Objectives: we aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The patients receive orthopedic surgery with older than 60 years old. They received high resolution impedance manometry examination at preoperative day, in the post-anesthetic care unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also followed the IDDSI guideline to test different viscosity of the patients' tolerance for food.

Expected result: The patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

We masked the participants, care provider and outcomes assessor.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patients receive orthopedic surgery with older than 60 years old including 60 years old.

排除标准

  • •The patients had severe major organ dysfunction

研究组 & 干预措施

endotracheal intubation

Placebo Comparator

under general anesthesia, patients received tracheal intubation.

干预措施: endotracheal intubation (Device)

supraglottic airway device

Experimental

under general anesthesia, patients received supraglottic airway device

干预措施: supraglottic airway device (Device)

结局指标

主要结局

hypopharyngeal mean peak pressure

时间窗: 15 minutes

hypopharyngeal pressure during food bolus transmittion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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