Development of Advanced Double Intravenous Vasopressor Automated (ADIVA)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03620942
Study type	Interventional
Source	KK Women's and Children's Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 7, 2018
Completion date	December 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms