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临床试验/NCT03721419
NCT03721419已完成不适用

Low-Flow (LF) Oxygen Versus Heated Humidified High-Flow (HF) Therapy Following Tracheostomy

Barnes-Jewish Hospital2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Days of Mechanical Ventilation (MV)

研究概览

简要总结

Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.

详细描述

Many patients with Respiratory Failure undergo tracheostomy due to difficulty weaning from mechanical ventilation. A component of weaning a patient with tracheostomy usually involves the administration of oxygen via High Humidity device. There are two major ways of administering oxygen via High Humidity to patients. They include low flow high humidity; delivered at less than or equal to 10LPM or high-flow humidity, delivered at greater than 10LPM. There is not a currently accepted standard of practice for how to administer oxygen high humidity to patients who receive a tracheostomy due to respiratory failure. Both Low and High Flow high humidity devices are used routinely by health care facilities nationwide. Therefore, the investigators plan to perform a crossover study in both a medicine and surgical Intensive Care Unit to determine which type of oxygen High Humidity therapy should be preferentially utilized. Patients in one Intensive Care Unit will start off with Low Flow high humidity while the alternate unit will start with Hi Flow high humidity. After one half of the required sample size is accrued the investigators will cross over the two ICUs to the alternate type of oxygen High Humidity device. No other respiratory practices will change during the conduct of this trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Single blind

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

  • Mechanically ventilated patients who receive tracheostomy

排除标准

  • Non-English speaking and pregnancy

结局指标

主要结局

Days of Mechanical Ventilation (MV)

时间窗: an average of 1 year

Time in days from initiation of MV until discontinuance of MV

次要结局

  • Days of ICU Stay(an average of 1 year)
  • Days of hospital stay(an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peggy Watts

Manager, Respiratory Therapy

Barnes-Jewish Hospital

研究点 (2)

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