A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability (DIVA)

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypotension

Treatments: Device: vasopressor delivery automated system; Drug: phenylephrine; Drug: ephedrine; Device: manual vasopressor delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT02277730

SHF/CTG047/2012

Details and patient eligibility

About

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Full description

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.

A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.

Enrollment: 252 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 21-45 years old,
• weight 40-90 kg,
• height 145-170 cm

Exclusion criteria

• contraindications to spinal anaesthesia,
• allergy to drugs used in the study, and
• those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

vasopressor delivery automated system

Experimental group

Description:

vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique

Treatment:

Drug: ephedrine

Drug: phenylephrine

Device: vasopressor delivery automated system

manual vasopressor delivery

Active Comparator group

Description:

manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique

Treatment:

Drug: ephedrine

Drug: phenylephrine

Device: manual vasopressor delivery