Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    300
  • sponsor
    KK Women's and Children's Hospital
Updated on 27 January 2021
anesthesia
vasopressor
vasoconstrictor
cesarean section
spinal anesthesia
ephedrine
elective cesarean delivery
maternal hypotension

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.

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 investigate the use of ADIVA in comparison to the existing DIVA system in patients undergoing spinal anaesthesia for Caesarean section. Demographic data, vital signs, amount of vasopressors, pain data, neonatal and maternal outcomes will be collected.

Details
Condition Hypotension, Low Blood Pressure (Hypotension), Vascular Diseases, Vascular Diseases, dental anesthesia, Anesthesia, Anesthesia (Local), Anesthesia, Low Blood Pressure (Hypotension), Anesthesia (Local), sensory loss, anaesthesia, anesthesia for, anesthesia procedures
Treatment Phenylephrine, Ephedrine, ADIVA System, DIVA System
Clinical Study IdentifierNCT03620942
SponsorKK Women's and Children's Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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