Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 26, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date March 8, 2018
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Hypotension [ Time Frame: 1 day ]
Systolic blood pressure less than 80% of baseline systolic blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Hypertension [ Time Frame: 1 day ]
    Systolic blood pressure more than 120% of baseline systolic blood pressure
  • Nausea and vomiting [ Time Frame: 1 day ]
    Nausea and vomiting during Caesarean section
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
Official Title  ICMJE A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypotension
Intervention  ICMJE
  • 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
  • Device: manual vasopressor delivery
Study Arms  ICMJE
  • Experimental: vasopressor delivery automated system
    vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
    Interventions:
    • Device: vasopressor delivery automated system
    • Drug: phenylephrine
    • Drug: ephedrine
  • Active Comparator: manual vasopressor delivery
    manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
    Interventions:
    • Drug: phenylephrine
    • Drug: ephedrine
    • Device: manual vasopressor delivery
Publications * Sng BL, Du W, Lee MX, Ithnin F, Mathur D, Leong WL, Sultana R, Han NR, Sia ATH. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2018 May;35(5):390-397. doi: 10.1097/EJA.0000000000000779.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
252
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2014)
286
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277730
Other Study ID Numbers  ICMJE SHF/CTG047/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party KK Women's and Children's Hospital
Study Sponsor  ICMJE KK Women's and Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital
PRS Account KK Women's and Children's Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP