跳至主要内容
临床试验/NCT02294422
NCT02294422已完成不适用

Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.

Makerere University2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
2
主要终点
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O

研究概览

简要总结

This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.

The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.

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 (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American society of anesthesiologists (ASA) physical status classes I-IV

排除标准

  • Known or anticipated laryngo-tracheal abnormalities.
  • Patients with cough, sore throat, dysphagia and dysphonia.
  • Patients in whom intubation is attempted more than twice

结局指标

主要结局

The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O

时间窗: 5minutes

This outcome will be measured within the first 5 minutes after intubation of the patient. The recommended range of intracuff pressure for this study is 20-30cmH2O

次要结局

  • Incidence of early postoperative airway symptoms(12 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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