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OpenTrials
Completed

NCT Number: NCT02277730

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

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.

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vasopressor delivery automated system

Device

vasopressor delivery using phenylephrine and ephedrine

Other names: vasopressor delivery technique

Phenylephrine

Drug

Other names: vasopressor

Ephedrine

Drug

Other names: vasopressor

manual vasopressor delivery

Device

Primary outcomes

  1. Hypotension

    Time frame: 1 day

    Systolic blood pressure less than 80% of baseline systolic blood pressure

Secondary outcomes

  1. Hypertension

    Time frame: 1 day

    Systolic blood pressure more than 120% of baseline systolic blood pressure

  2. Nausea and vomiting

    Time frame: 1 day

    Nausea and vomiting during Caesarean section

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Acronym: DIVA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2014
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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