Clinical trial NCT02804022: Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Respiratory Depression
Keywords: Respiratory Depression
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-06-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of episodes of breech in safety thresholds
timeFrame: 2 days
Secondary outcomes:
measure: Pain scores
timeFrame: 2 or 3 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sng BL, Tan DJ, Tan CW, Han NR, Sultana R, Sia ATH. A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain. BMC Anesthesiol. 2020 Jun 8;20(1):145. doi: 10.1186/s12871-020-01060-4.