Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Hypotension
Interventions
DEVICE

Vasopressor automated delivery system

"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."

DRUG

Phenylephrine

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.

DRUG

Ephedrine

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.

DEVICE

Manual vasopressor delivery system

"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."

All Listed Sponsors
lead

KK Women's and Children's Hospital

OTHER_GOV

NCT04025918 - Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section | Biotech Hunter | Biotech Hunter