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临床试验/NCT03100669
NCT03100669已完成不适用

Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program: Short and Long-term Evaluation of Pain, Nausea, Sleep, and Rehabilitation Via Tele-monitoring

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年5月1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
47
试验地点
1
主要终点
Pain

研究概览

简要总结

MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.

详细描述

In order to provide pain patients with an individualized approach to their pain problem after MIRP we developed an electronic medical record coupled to a set of telemetric medical-grade devices. Appi@Home (Antwerp Personalized Pain Initiative) supports an innovative approach to (sub)acute conditions by offering a platform for continuous follow-up. Patients are provided with a toolbox and an app that continuously collects objective outcome data (i.e. pain intensity, sleep quality, physical activity). The integrated system allows the care givers to respond very quickly to changing clinical conditions of the patient, making a very adaptive and individualized follow-up possible for these patients. In addition, the patient becomes an active participant in the global therapeutic approach.

Patients receive the toolbox two week prior to surgery with access to the internet platform for questionnaires fill-in procedure. Up to ten week after surgery pain intensity, sleep quality and physical activity will be monitored subjectively by a scoring table (0-10, 0 no pain-bad sleeping quality-no activity, 10 maximum of pain-excellent sleeping quality- a lot of activity) and objectively by blood pressure device, oxygen saturation monitoring, activity tracker and sleep registration tool.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •elective pectus repair
  • •signed informed consent

排除标准

  • •chronic opioid use (> 3 months)
  • •history of ongoing psychiatric disease

结局指标

主要结局

Pain

时间窗: 10 weeks after surgery

pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery

次要结局

  • Daily activity(2 weeks before up to 10 weeks after surgery)
  • Nausea(From day of surgery until hospital discharge (approximately 7 days))
  • Mobility(From day of surgery until hospital discharge (approximately 7 days))
  • Sleep(2 weeks before up to 10 weeks after surgery)

研究者

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

Davina Wildemeersch

Resident anesthesiology

University Hospital, Antwerp

研究点 (1)

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