Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section
1 other identifier
interventional
216
0 countries
N/A
Brief Summary
Hypotension occurs commonly during spinal anesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive arterial pressure monitoring (CNAP, CNSystems, Austria).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Shorter than P25 for phase_2
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
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedJuly 19, 2019
July 1, 2019
9 months
July 17, 2019
July 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypotension
Incidence of 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 that administered phenylephrine and ephedrine based on data from continuous non-invasive hemodynamic monitor
manual vasopressor delivery
ACTIVE COMPARATORmanual bolus that delivered phenylephrine and ephedrine based on data from non-invasive intermitted blood pressure monitor
Interventions
Novel closed-loop system incorporating: 1. Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time. 2. Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered. 3. Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm.
Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm.
Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm.
Manual dosing system consisting: 1. Non-invasive intermittent blood pressure monitor that measured and recorded blood pressure at 1-minute intervals. 2. Attending anesthesiologist that noted the blood pressure readings and manually administered phenylephrine or ephedrine according to the algorithm.
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
Related Publications (3)
Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.
PMID: 20173633BACKGROUNDSia AT, Tan HS, Sng BL. Closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: a preliminary study. Anaesthesia. 2012 Dec;67(12):1348-55. doi: 10.1111/anae.12000. Epub 2012 Sep 28.
PMID: 23020653BACKGROUNDSng BL, Tan HS, Sia AT. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial. Anaesthesia. 2014 Jan;69(1):37-45. doi: 10.1111/anae.12460. Epub 2013 Nov 20.
PMID: 24256483RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ban Leong Sng, FANZCA
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 19, 2019
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share