Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia

Respiratory Depression Clinical Trial

— VPIAmorphine  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02804022
• Other study ID #: 2015/3062
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 29, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Respiratory Depression
• Respiratory Insufficiency

Intervention

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.

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

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of breech in safety thresholds	Any episode of oxygen saturation <95%, Heart rate <60 bpm or Respiratory rate <8 breaths/min	2 days
Secondary	Pain scores	Visual pain score 0-10	2 or 3 days