Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System (ADIVA)

August 12, 2026 updated by: Sng Ban Leong, KK Women's and Children's Hospital

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section

Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of maternal hypotension during spinal anaesthesia for Caesarean delivery is reported to be as high as 70-90%. The potential adverse effects resulting from maternal hypotension are nausea, vomiting, cardiac dysfunction, foetal acidosis and hypoxia.

Hypotension during spinal anaesthesia is currently detected using an intermittent blood pressure (BP) monitor cycling and reactive administration of vasopressors upon detection. The use of conventional non-invasive BP monitoring is limited by the time required to inflate and to deflate the cuffs commonly applied to the arm, which subsequently leads to a failure to react in a timely manner to BP changes when they occur.

The DIVA system (double-intravenous vasopressor automated system) previously developed helped tackle the limitations associated with the conventional management of hypotension in Caesarean sections under spinal anaesthesia. In a recent randomized controlled trial the DIVA system achieved less incidence of maternal hypotension compared to conventional management, however the side effects in mother and baby were still not fully eliminated.

In this proposed study a new algorithm for an advanced DIVA (ADIVA) system will be developed to control BP more rigorously by detecting BP with more stable haemodynamic profiles and thereby improve patient outcomes. The clinical trial will be conducted in 2 phases. The first phase included the use of ADIVA in 76 subjects who undergo spinal anaesthesia for Caesarean delivery to test its safety and efficacy. The second phase was a randomised controlled trial to investigate the use of ADIVA in comparison to the existing DIVA system in 97 patients undergoing spinal anaesthesia for Caesarean section.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

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 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients;
  • With singleton full-term pregnancy;
  • The indication for an elective cesarean delivery;
  • The use of spinal anaesthesia for cesarean delivery;
  • Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm.

Exclusion Criteria:

  • Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
  • Contraindication to spinal anaesthesia and/or allergy to opioids.

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: ADIVA system
Vasopressor delivery automated system administering phenylephrine and ephedrine using a three-step algorithm vasopressor delivery technique
Drug: Phenylephrine

Phenylephrine will be administered with conditions as below:

  1. When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min;
  2. When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min.
Other Names:
  • Vasopressor
Drug: Ephedrine

Ephedrine will be administered with conditions as below:

  1. When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min;
  2. When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min.
Other Names:
  • Vasopressor
Device: ADIVA System
  1. When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate < 60 beats/min;
  2. When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
  3. When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
  4. When SBP < 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min.
Other Names:
  • Advanced Double Intravenous Vasopressor Automated System
Active Comparator: DIVA system
Vasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique
Drug: Phenylephrine

Phenylephrine will be administered with conditions as below:

  1. When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min;
  2. When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min.
Other Names:
  • Vasopressor
Drug: Ephedrine

Ephedrine will be administered with conditions as below:

  1. When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min;
  2. When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min.
Other Names:
  • Vasopressor
Device: DIVA System

DIVA system works as below:

  1. When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate < 60 beats/min;
  2. When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate < 60 beats/min.
Other Names:
  • Double Intravenous Vasopressor Automated System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of events of Hypotension occurrence
Time Frame: 1 day (during cesarean delivery)
Systolic blood pressure less than 80% of baseline systolic blood pressure
1 day (during cesarean delivery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of events of Hypertension occurrence
Time Frame: 1 day (during cesarean delivery)
Systolic blood pressure more than 120% of baseline systolic blood pressure
1 day (during cesarean delivery)
Number of events of Nausea and vomiting occurrence
Time Frame: 1 day (during and after cesarean delivery)
Nausea and vomiting during and after cesarean delivery
1 day (during and after cesarean delivery)

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: Singaraselvan Nagarajan, FCARCSI, 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)

November 7, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 5, 2018

First Submitted That Met QC Criteria

August 5, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHF/CTG061/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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