Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia (VPIAmorphine)
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|ClinicalTrials.gov Identifier: NCT02804022|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Depression||Device: VPIA analgesia Drug: Morphine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia for Postsurgical Pain: A Novel Modality to Improve Patient Safety by Detecting and Preventing Respiratory Depression|
|Actual Study Start Date :||December 29, 2016|
|Actual Primary Completion Date :||May 30, 2017|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: 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.
Device: VPIA analgesia
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.
Other Name: VPIA delivery system
Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.
Other Name: Morphine-VPIA
- Number of episodes of breech in safety thresholds [ Time Frame: 2 days ]Any episode of oxygen saturation <95%, Heart rate <60 bpm or Respiratory rate <8 breaths/min
- Pain scores [ Time Frame: 2 or 3 days ]Visual pain score 0-10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804022
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Ban L Sng, FANZCA||KK Women's and Children's Hospital|