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临床试验/NCT06239831
NCT06239831招募中不适用

Postoperative Respiratory and Activity Monitoring

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Hypoventilation

研究概览

简要总结

This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.

详细描述

Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.

Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be 18 or older
  • Must be undergoing abdominal surgery
  • Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)

排除标准

  • Anyone under 18
  • Anyone not undergoing abdominal surgery
  • Anyone that is not high-risk for PPCs (ARISCAT score less than 26)

结局指标

主要结局

Hypoventilation

时间窗: First 3 postoperative days

Minutes per hour of hypoventilation which is defined as \<40% of a predicted minute ventilation volume

次要结局

  • Duration of high TV(Through postoperative day 3)
  • Variability of MV(Through postoperative day 3)
  • Variability of VT(Through postoperative day 3)
  • Events of Low MV(Through postoperative day 3)
  • Events of Low VT(Through postoperative day 3)
  • Time Spent in Sitting(Through postoperative day 3)
  • Variability of RR(Through postoperative day 3)
  • Percentage of time free of low or high MV(Through postoperative day 3)
  • Events of Low RR(Through postoperative day 3)
  • Percentage of time free of low or high VT(Through postoperative day 3)
  • Percentage of time free of low or high RR(Through postoperative day 3)
  • Duration of low MV(Through postoperative day 3)
  • Duration of low VT(Through postoperative day 3)
  • Postoperative Pulmonary Complication (PPC) Severity(Through postoperative day 7)
  • Time After Surgery to Ambulating(Through postoperative day 3)
  • Total Minutes Walking(Through postoperative day 3)
  • Frequency of Ambulation(Through postoperative day 3)
  • Time Spent in Bed(Through postoperative day 3)
  • Duration of low RR(Through postoperative day 3)
  • Duration of high RR(Through postoperative day 3)
  • Postoperative Pulmonary Complication (PPC) Incidence(Through postoperative day 7)
  • Duration of high MV(Through postoperative day 3)
  • Time After Surgery to Sitting(Through postoperative day 3)
  • Total Walking Distance(Through postoperative day 3)
  • Time Spent Standing(Through postoperative day 3)
  • Time Spent Walking(Through postoperative day 3)
  • Average Speed of Ambulation(Through postoperative day 3)
  • Adverse events(Through postoperative day 7)
  • Metabolic Equivalent of Task (MET) Score of Physical Activity(Through postoperative day 3)
  • First Postoperative Day Achieving Independent Ambulation(Through postoperative day 3)
  • Other complications(Through postoperative day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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