Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Respiratory Depression

Intervention / Treatment
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* Device: VPIA analgesia
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnant

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VPIA analgesia system<br>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. | Device: VPIA analgesia<br>* Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line with an anti-reflux valve to ensure precise drug administration and no backflow.<br>* Other names: VPIA delivery system;Drug: Morphine<br>* Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.<br>* Other names: Morphine-VPIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of breech in safety thresholds | Any episode of oxygen saturation <95%, Heart rate <60 bpm or Respiratory rate <8 breaths/min | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Visual pain score 0-10 | 2 or 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Depression