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

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02277730
Collaborator
(none)
252
Enrollment
1
Location
2
Arms
55
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: vasopressor delivery automated system

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

Device: vasopressor delivery automated system
vasopressor delivery using phenylephrine and ephedrine
Other Names:
  • vasopressor delivery technique

    • Drug: phenylephrine
    Other Names:
  • vasopressor

    • Drug: ephedrine
    Other Names:
  • vasopressor

    		•
    Active Comparator: manual vasopressor delivery

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

    Drug: phenylephrine
    Other Names:
  • vasopressor

    • Drug: ephedrine
    Other Names:
  • vasopressor

    • Device: manual vasopressor delivery

    Outcome Measures

    Primary Outcome Measures

    1. Hypotension [1 day]

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

    Secondary Outcome Measures

    1. Hypertension [1 day]

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

    2. Nausea and vomiting [1 day]

      Nausea and vomiting during Caesarean section

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KK Women's and Children's Hospital Singapore Singapore 229899

    Sponsors and Collaborators

    • KK Women's and Children's Hospital

    Investigators

    • Principal Investigator: Ban L Sng, FANZCA, KK Women's and Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KK Women's and Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02277730
    Other Study ID Numbers:
    • SHF/CTG047/2012
    First Posted:
    Oct 29, 2014
    Last Update Posted:
    Mar 8, 2018
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by KK Women's and Children's Hospital
    Hypotension
    Additional relevant MeSH terms:
    Hypotension
    Phenylephrine
    Oxymetazoline
    Ephedrine
    Vasoconstrictor Agents

    Study Results

    No Results Posted as of Mar 8, 2018