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VPIAmorphine: Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02804022
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Dec 29, 2016
Actual Primary Completion Date :
May 30, 2017
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • VPIA delivery system

    • Drug: Morphine
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of episodes of breech in safety thresholds [2 days]

      Any episode of oxygen saturation <95%, Heart rate <60 bpm or Respiratory rate <8 breaths/min

    Secondary Outcome Measures

    1. Pain scores [2 or 3 days]

      Visual pain score 0-10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KK Women's and Children's Hospital Singapore Singapore 229899

    Sponsors and Collaborators

    • KK Women's and Children's Hospital

    Investigators

    • Principal Investigator: Ban L Sng, FANZCA, KK Women's and Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KK Women's and Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02804022
    Other Study ID Numbers:
    • 2015/3062
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by KK Women's and Children's Hospital
    Respiratory Depression
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Depression
    Depressive Disorder
    Morphine

    Study Results

    No Results Posted as of Mar 31, 2022