Respiratory DepressionPhase 2VPIAmorphineNCT02804022
Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia
A Phase 2 study testing VPIA analgesia and Morphine in people with Respiratory Depression, run by KK Women's and Children's Hospital at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- VPIA analgesia and Morphine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Dec 2016to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Depression
- Being tested
- VPIA analgesia, Morphine
- Keywords
- Respiratory Depression
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPIA analgesiaDevice
Also called VPIA delivery system
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.
MorphineDrug
Also called Morphine-VPIA
Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.
| Study group | Role | What they receive |
|---|---|---|
| VPIA analgesia system | Experimental | 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. Receives: Device: VPIA analgesia; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of breech in safety thresholds
Any episode of oxygen saturation <95%, Heart rate <60 bpm or Respiratory rate <8 breaths/min
Measured: 2 days
Secondary outcomes (1)
Pain scores
Visual pain score 0-10
Measured: 2 or 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start29 Dec 2016
- Primary completion30 May 2017
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804022
- Sponsor's protocol ID
- 2015/3062
- Acronym
- VPIAmorphine
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2016
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32513113
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02804022
- Acronym / sponsor ID
- VPIAmorphine / 2015/3062
- Conditions
- Respiratory Depression
- Keywords
- Respiratory Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPIA analgesia system | Experimental | Device: VPIA analgesia, Drug: MorphineVital-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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPIA analgesiaAlso: VPIA delivery systemRecruited 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. | Device | VPIA analgesia system |
| MorphineAlso: Morphine-VPIARecruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line. | Drug | VPIA analgesia system |
Primary outcome
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
1 secondary outcome
Pain scores
Time frame: 2 or 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 32513113Sng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VPIA analgesia and Morphine in people with Respiratory Depression, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of breech in safety thresholds (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.