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临床试验/NCT02804022
NCT02804022进行中(未招募)2 期

Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia for Postsurgical Pain: A Novel Modality to Improve Patient Safety by Detecting and Preventing Respiratory Depression

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年12月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Number of episodes of breech in safety thresholds

研究概览

简要总结

This is a closed-loop system which is embodied in a novel and intelligent algorithm that takes into account patients' vital signs. The system allows better and responsive titration of personalized pain relief together with non-invasive physiological monitoring that measures oxygenation, breathing and heart rate continuously.

详细描述

A glaring safety gap in the administration of commonplace Patient Controlled Analgesia (PCA) opioids unfortunately exists. A significant proportion of patients may suffer from respiratory depression with the use of PCA opioids and it is imperative to discover solutions to improve the safety of PCA opioids, therein improving medication safety, enhancing quality of postoperative care and providing economic cost savings. Currently, no continuous monitoring system that integrates an intelligent decision making response exists.

The investigators primary aim is to develop and commercialise a Vital-signs-integrated (using oxygen saturation, respiratory rate, heart rate) Patient-assisted Intravenous opioid Analgesia (VPIA) that can be integrated into the hospital-wide monitoring systems is capable of making intelligent decision making responses to bridge the PCA safety gap within 12 months.

This VPIA delivery system will be a closed-loop system for safety and efficacy. It will be integrated with continuous vital signs monitoring, and provide appropriate response to breach of safety parameters. It will be part of a larger surveillance system that provides tiered medical and nursing alerts to safety parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age 21-70 years old, female
  • •Healthy participants who are American Society of Anesthesiologists physical status 1 and 2 (with well controlled medical problems)
  • •Undergoing elective surgery with the intent of using postoperative PCA with morphine for postoperative analgesia

排除标准

  • •Allergy to morphine
  • •With significant respiratory disease and obstructive sleep apnea
  • •Unwilling to place oxygen saturation monitoring devices during study period
  • •Unable to comprehend the use of patient controlled analgesia

研究组 & 干预措施

VPIA analgesia system

Experimental

Vital-signs-integrated patient-assisted intravenous opioid analgesia system (VPIA). The vital signs (oxygen saturation, respiratory rate, heart rate) will be close monitored when patients is using VPIA pump. The drug used is intravenous morphine (1mg per milligram) with bolus of 1 mg.

干预措施: VPIA analgesia (Device)

VPIA analgesia system

Experimental

Vital-signs-integrated patient-assisted intravenous opioid analgesia system (VPIA). The vital signs (oxygen saturation, respiratory rate, heart rate) will be close monitored when patients is using VPIA pump. The drug used is intravenous morphine (1mg per milligram) with bolus of 1 mg.

干预措施: Morphine (Drug)

结局指标

主要结局

Number of episodes of breech in safety thresholds

时间窗: 2 days

Any episode of oxygen saturation \<95%, Heart rate \<60 bpm or Respiratory rate \<8 breaths/min

次要结局

  • Pain scores(2 or 3 days)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sng Ban Leong

Principal Investigator

KK Women's and Children's Hospital

研究点 (1)

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