A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability
DIVA
1 other identifier
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 8, 2018
August 1, 2017
4.5 years
October 26, 2014
March 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypotension
Systolic blood pressure less than 80% of baseline systolic blood pressure
1 day
Secondary Outcomes (2)
Hypertension
1 day
Nausea and vomiting
1 day
Study Arms (2)
vasopressor delivery automated system
EXPERIMENTALvasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
manual vasopressor delivery
ACTIVE COMPARATORmanual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
Interventions
vasopressor delivery using phenylephrine and ephedrine
Eligibility Criteria
You may qualify if:
- age 21-45 years old,
- weight 40-90 kg,
- height 145-170 cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Related Publications (2)
Du EW, Tan HS, Tan CW, Sultana R, Sng BL. Heart rate variability and haemodynamic factors associated with hypotension during spinal anaesthesia for caesarean delivery: A case-control study. Eur J Anaesthesiol. 2022 Mar 1;39(3):219-226. doi: 10.1097/EJA.0000000000001551.
PMID: 34101716DERIVEDSng 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.
PMID: 29373334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ban L Sng, FANZCA
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2014
First Posted
October 29, 2014
Study Start
May 1, 2013
Primary Completion
November 1, 2017
Study Completion
December 1, 2017
Last Updated
March 8, 2018
Record last verified: 2017-08