Clinical trial NCT03620942: Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System
Official title: Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypotension
Anesthesia
Keywords: Maternal hypotension
Spinal anaesthesia
Caesarean section
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-08
Enrollment: 173
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first phase recruited 76 parturients. The second phase recruited 97 parturients. Parturients recruited from this phase will be randomized into either ADIVA group or DIVA group.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of events of Hypotension occurrence
timeFrame: 1 day (during cesarean delivery)
Secondary outcomes:
measure: Number of events of Hypertension occurrence
timeFrame: 1 day (during cesarean delivery)
measure: Number of events of Nausea and vomiting occurrence
timeFrame: 1 day (during and after cesarean delivery)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Singaraselvan Nagarajan, FCARCSI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagarajan S, Chan JJI, Tan CW, Al-Hashim ZGA, Sultana R, Sia ATH, Sng BL. An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study. Eur J Anaesthesiol. 2022 Jan 1;39(1):42-49. doi: 10.1097/EJA.0000000000001496.