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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPIA analgesia | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Visual pain score 0-10 | 2 or 3 days |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients undergoing elective surgery in this institution will be recruited. The study site is specialised in providing healthcare only to women and children in Singapore.
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| Name | Affiliation | Role |
|---|---|---|
| Ban L Sng, FANZCA | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32513113 | Derived | Sng BL, Tan DJ, Tan CW, Han NR, Sultana R, Sia ATH. A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain. BMC Anesthesiol. 2020 Jun 8;20(1):145. doi: 10.1186/s12871-020-01060-4. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Morphine | Drug | Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line. |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |