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

• ClinicalTrials.gov Identifier: NCT02277730
• Recruitment Status: Completed
• First Posted: October 29, 2014
• Last Update Posted: March 8, 2018
• Sponsor: KK Women's and Children's Hospital
• Information provided by (Responsible Party): KK Women's and Children's Hospital

Tracking Information

• First Submitted Date: October 26, 2014
• First Posted Date: October 29, 2014
• Last Update Posted Date: March 8, 2018
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 28, 2014)

Hypotension [ Time Frame: 1 day ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hypotension

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 10, 2017): 252
• Original Estimated Enrollment (submitted: October 28, 2014): 286
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02277730
• Other Study ID Numbers: SHF/CTG047/2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: KK Women's and Children's Hospital
• Study Sponsor: KK Women's and Children's Hospital
• Collaborators: Not Provided

Investigators

• 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