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NCT Number: NCT02804022

Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: VPIA delivery system

Morphine

Drug

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

Other names: Morphine-VPIA

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain scores

    Time frame: 2 or 3 days

    Visual pain score 0-10

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study 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

Acronym: VPIAmorphine

Important dates

Study start
2016
Primary completion
2017
Study completion
2025
First posted
Jun 17, 2016
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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