- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620942
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System (ADIVA)
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Phenylephrine will be administered with conditions as below:
Other Names:
Ephedrine will be administered with conditions as below:
Other Names:
Other Names:
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Active Comparator: DIVA system
Vasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique
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Phenylephrine will be administered with conditions as below:
Other Names:
Ephedrine will be administered with conditions as below:
Other Names:
DIVA system works as below:
Other Names:
|
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)
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Systolic blood pressure less than 80% of baseline systolic blood pressure
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1 day (during cesarean delivery)
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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
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1 day (during cesarean delivery)
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Number of events of Nausea and vomiting occurrence
Time Frame: 1 day (during and after cesarean delivery)
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Nausea and vomiting during and after cesarean delivery
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1 day (during and after cesarean delivery)
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Collaborators and Investigators
Investigators
- Principal Investigator: Singaraselvan Nagarajan, FCARCSI, KK Women's and Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Ephedrine
- Phenylephrine
- Oxymetazoline
- Vasoconstrictor Agents
Other Study ID Numbers
- SHF/CTG061/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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