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临床试验/NCT03944967
NCT03944967已完成不适用

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2020年3月5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
71
试验地点
1
主要终点
Respiratory deterioration

研究概览

简要总结

A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.

  • Single center pilot study.
  • 100 older patients undergoing cardiac surgery.
  • Continuous remote monitoring of vital signs after ICU discharge
  • Main study endpoint is vital sign deterioration.

详细描述

Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.

To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..

  • Single center pilot study.
  • 100 older patients undergoing cardiac surgery.
  • Continuous remote monitoring of vital signs starts after ICU discharge
  • PR, RR and SpO2 will be continuously monitored in all patients.
  • Patients and healthcare personnel are blinded for monitoring results.
  • Main study endpoint is vital sign deterioration.

The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • ≥70 years undergoing elective cardiac surgery.

排除标准

  • 未提供

结局指标

主要结局

Respiratory deterioration

时间窗: Three consecutive days after ICU discharge

Duration of respiratory rate \<10 min-1, \>20 min-1, \>25 min-1, \>30 min-1 in minutes per hour

Arrythmia

时间窗: Three consecutive days after ICU discharge

Duration of pulse rate \<50 min-1, \>100 min-1, \>110 min-1, \>120 min-1 in minutes per hour

Hypoxemia

时间窗: Three consecutive days after ICU discharge

Duration of sPO2 \<80%, \<85%, \<90% and \<95% in minutes per hour

次要结局

未报告次要终点

研究者

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

dr. P. Noordzij

PI

St. Antonius Hospital

研究点 (1)

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