Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

Phase 2

Active, not recruiting

• Conditions: Respiratory Depression
• Interventions: Device: VPIA analgesia; Drug: Morphine

• Registration Number: NCT02804022
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-02-28
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Study Start: 2016-12-29
• Primary Completion: 2017-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VPIA analgesia system	VPIA analgesia	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.
VPIA analgesia system	Morphine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pain scores	2 or 3 days	Visual pain score 0-10

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore