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临床试验/NCT04231890
NCT04231890已完成不适用

Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index: A Randomized Controlled Trial

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2020年3月9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
174
试验地点
2
主要终点
Reintubation rate at 72hours

研究概览

简要总结

The primary aim of this study is to compare reintubation rate when using standard medical therapy (SMT) versus a monitoring tool, Integrated Pulmonary Index (IPI), to alert clinicians of the patient's respiratory status and need for therapy after planned extubation.

详细描述

The study is designed as a randomized controlled trial to compare two methods to guide application of clinical interventions after planned extubation: SMT versus IPI based clinical management among adult patients admitted in the ICU and receiving mechanical ventilation for ≥24 hours. Each mechanically ventilated subject within the inclusion criteria and with a physician order for extubation will be randomized to either the SMT or IPI based clinical management group. Once the extubation order is placed by the medical team, the patient will be randomized to IPI monitoring group or standard medical management group. Patients randomized to IPI group will be placed on IPI monitoring after extubation.Respiratory Therapist (RT) will extubate and connects the patient to EtCO2 cannula (Medtronic, Minneapolis, MN) and will turn on IPI monitoring on the Philips monitor. Any subject with decrease in IPI by 1 within 1 hour of extubation or IPI ≤ 4 after 1 hour of extubation will be assessed by RT and will receive standard medical therapy based on respiratory department protocols. IPI monitoring will be continued for up to 72 hours after extubation. Patients randomized to control group will receive standard medical therapy based on the respiratory department protocols. All patients will be clinically monitored for 72 hours after extubation to assess the extubation outcome. Patients that require reintubation will be reintubated based on the medical team decision and will be discontinued from the study. Patients that do not require reintubation after 72 hours will successfully complete the study.

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

  • Adult subjects 18 years and older, endotracheally intubated and receiving assisted mechanical ventilation for more than 24hours, and
  • Subjects under planned extubation based on the medical team approval

排除标准

  • Subjects who are less than 18 years old,
  • are pregnant,
  • have tracheostomy tube as they do not qualify for extubation,
  • have do-not-resuscitate or do-not-intubate orders,
  • accidental or self-extubated patients,
  • reintubation after study enrollment,
  • are extubated terminally, or
  • receiving extracorporeal membrane oxygenation (ECMO)

结局指标

主要结局

Reintubation rate at 72hours

时间窗: 72 hours

Reintubation rate defined as requiring re-intubation and returning to mechanical ventilation within 72 hours after the initial discontinuation from the ventilation due to respiratory failure

次要结局

  • ICU length of stay(upto 12 weeks)
  • Reintubation rate at 7 days(7 days)
  • ICU mortality(upto 12 weeks)

研究者

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

Ramandeep Kaur

Research Coordinator; MSc, RRT-ACCS, AE-C

Rush University Medical Center

研究点 (2)

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