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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277730
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Study Description
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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
Hypotension Device: vasopressor delivery automated system Drug: phenylephrine Drug: ephedrine Device: manual vasopressor delivery 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
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Study Type : Interventional  (Clinical Trial)
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 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: vasopressor delivery technique

Drug: phenylephrine
Other Name: vasopressor

Drug: ephedrine
Other Name: vasopressor
Active Comparator: manual vasopressor delivery
manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
 Drug: phenylephrine
Other Name: vasopressor

Drug: ephedrine
Other Name: vasopressor

Device: manual vasopressor delivery


Outcome Measures
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Primary Outcome Measures :
  1. Hypotension [ Time Frame: 1 day ]
    Systolic blood pressure less than 80% of baseline systolic blood pressure


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277730


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02277730    
Other Study ID Numbers: SHF/CTG047/2012
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by KK Women's and Children's Hospital:
Hypotension
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Ephedrine
Vasoconstrictor Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants