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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
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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
Respiratory Depression Device: VPIA analgesia Drug: Morphine 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 29, 2016
Actual Primary Completion Date : May 30, 2017
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Morphine-VPIA




Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain scores [ Time Frame: 2 or 3 days ]
    Visual pain score 0-10



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02804022    
Other Study ID Numbers: 2015/3062
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by KK Women's and Children's Hospital:
Respiratory Depression
Additional relevant MeSH terms:
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Respiratory Insufficiency
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents