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

Phase 2

Completed

• Conditions: Hypotension
• Interventions: Device: vasopressor delivery automated system; Drug: phenylephrine; Device: manual vasopressor delivery; Drug: ephedrine

• Registration Number: NCT02277730
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-10-26
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Status Verified: 2017-08
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vasopressor delivery automated system	vasopressor delivery automated system	vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
manual vasopressor delivery	manual vasopressor delivery	manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
vasopressor delivery automated system	phenylephrine	vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
manual vasopressor delivery	phenylephrine	manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
vasopressor delivery automated system	ephedrine	vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
manual vasopressor delivery	ephedrine	manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique

Primary Outcome Measures

Name	Time	Method
Hypotension	1 day	Systolic blood pressure less than 80% of baseline systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	1 day	Nausea and vomiting during Caesarean section
Hypertension	1 day	Systolic blood pressure more than 120% of baseline systolic blood pressure

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore