HypotensionPhase 2/3DIVANCT02277730
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
A Phase 2/3 study testing vasopressor delivery automated system, phenylephrine and ephedrine in people with Hypotension, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- vasopressor delivery automated system, phenylephrine and ephedrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSingapore
- Study dates
- May 2013to Dec 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 21-45 years old,
- weight 40-90 kg,
- height 145-170 cm
Who cannot join
- contraindications to spinal anaesthesia,
- allergy to drugs used in the study, and
- those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.
Read the detailed description
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.
A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.
- Conditions
- Hypotension
- Being tested
- vasopressor delivery automated system, phenylephrine, ephedrine, manual vasopressor delivery
- Keywords
- Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressor delivery automated systemDevice
Also called vasopressor delivery technique
vasopressor delivery using phenylephrine and ephedrine
phenylephrineDrug
Also called vasopressor
ephedrineDrug
Also called vasopressor
manual vasopressor deliveryDevice
| Study group | Role | What they receive |
|---|---|---|
| vasopressor delivery automated system | Experimental | vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique Receives: Device: vasopressor delivery automated system; Drug: phenylephrine; Drug: ephedrine |
| manual vasopressor delivery | Active comparator | manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique Receives: Drug: phenylephrine; Drug: ephedrine; Device: manual vasopressor delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Systolic blood pressure less than 80% of baseline systolic blood pressure
Measured: 1 day
Secondary outcomes (2)
Hypertension
Systolic blood pressure more than 120% of baseline systolic blood pressure
Measured: 1 day
Nausea and vomiting
Nausea and vomiting during Caesarean section
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMay 2013
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 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
- NCT02277730
- Sponsor's protocol ID
- SHF/CTG047/2012
- Acronym
- DIVA
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2014
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Du EW, Tan HS, Tan CW, Sultana R, Sng BL. Heart rate variability and haemodynamic factors associated with hypotension during spinal anaesthesia for caesarean delivery: A case-control study. Eur J Anaesthesiol. 2022 Mar 1;39(3):219-226. doi: 10.1097/EJA.0000000000001551.
PubMed 34101716Sng BL, Du W, Lee MX, Ithnin F, Mathur D, Leong WL, Sultana R, Han NR, Sia ATH. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2018 May;35(5):390-397. doi: 10.1097/EJA.0000000000000779.
PubMed 29373334
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
- ClinicalTrials.gov ID
- NCT02277730
- Acronym / sponsor ID
- DIVA / SHF/CTG047/2012
- Conditions
- Hypotension
- Keywords
- Hypotension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- May 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Oct 2014 (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.
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.
Detailed description
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.
A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vasopressor delivery automated system | Experimental | Device: vasopressor delivery automated system, Drug: phenylephrine, Drug: ephedrinevasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique |
| manual vasopressor delivery | Active comparator | Drug: phenylephrine, Drug: ephedrine, Device: manual vasopressor deliverymanual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 21-45 years old,
- weight 40-90 kg,
- height 145-170 cm
Key exclusion criteria (3 listed)
- contraindications to spinal anaesthesia,
- allergy to drugs used in the study, and
- those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease
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 |
|---|---|---|
| vasopressor delivery automated systemAlso: vasopressor delivery techniquevasopressor delivery using phenylephrine and ephedrine | Device | vasopressor delivery automated system |
| phenylephrineAlso: vasopressor | Drug | manual vasopressor delivery, vasopressor delivery automated system |
| ephedrineAlso: vasopressor | Drug | manual vasopressor delivery, vasopressor delivery automated system |
| manual vasopressor delivery | Device | manual vasopressor delivery |
Primary outcome
Hypotension
Time frame: 1 day
Systolic blood pressure less than 80% of baseline systolic blood pressure
2 secondary outcomes
Hypertension
Time frame: 1 day
Nausea and vomiting
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 34101716Du EW, Tan HS, Tan CW, Sultana R, Sng BL. Heart rate variability and haemodynamic factors associated with hypotension during spinal anaesthesia for caesarean delivery: A case-control study. Eur J Anaesthesiol. 2022 Mar 1;39(3):219-226. doi: 10.1097/EJA.0000000000001551.
- Derived from this study: PubMed 29373334Sng BL, Du W, Lee MX, Ithnin F, Mathur D, Leong WL, Sultana R, Han NR, Sia ATH. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2018 May;35(5):390-397. doi: 10.1097/EJA.0000000000000779.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing vasopressor delivery automated system, phenylephrine and ephedrine in people with Hypotension, 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 3 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: finished, as of the sponsor's last update on 7 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypotension (time frame: 1 day). 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 NCT02277730, which also lists 2 linked publications.
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 7 Aug 2026.