Skip to content

Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804022
Acronym
VPIAmorphine
Enrollment
20
Registered
2016-06-17
Start date
2016-12-29
Completion date
2027-12-31
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression

Keywords

Respiratory Depression

Brief summary

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

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.

Interventions

DEVICEVPIA 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.

DRUGMorphine

Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of episodes of breech in safety thresholds2 daysAny episode of oxygen saturation \<95%, Heart rate \<60 bpm or Respiratory rate \<8 breaths/min

Secondary

MeasureTime frameDescription
Pain scores2 or 3 daysVisual pain score 0-10

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORBan L Sng, FANZCA

KK Women's and Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026