Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia for Postsurgical Pain: A Novel Modality to Improve Patient Safety by Detecting and Preventing Respiratory Depression
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
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
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
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital
