A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability (DIVA)

August 4, 2026 updated by: Sng Ban Leong, KK Women's and Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 21-45 years old,
  • weight 40-90 kg,
  • height 145-170 cm

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vasopressor delivery automated system
vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
Drug: phenylephrine
Other Names:
  • vasopressor
Drug: ephedrine
Other Names:
  • vasopressor
Device: vasopressor delivery automated system
vasopressor delivery using phenylephrine and ephedrine
Other Names:
  • vasopressor delivery technique
Active Comparator: manual vasopressor delivery
manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
Drug: phenylephrine
Other Names:
  • vasopressor
Drug: ephedrine
Other Names:
  • vasopressor
Device: manual vasopressor delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: 1 day
Systolic blood pressure less than 80% of baseline systolic blood pressure
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: 1 day
Systolic blood pressure more than 120% of baseline systolic blood pressure
1 day
Nausea and vomiting
Time Frame: 1 day
Nausea and vomiting during Caesarean section
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Ban L Sng, FANZCA, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimated)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHF/CTG047/2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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