Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

NAActive, not recruitingINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
HypotensionAnesthesia
Interventions
DRUG

Phenylephrine

"Phenylephrine will be administered with conditions as below:~1. When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min;~2. When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min."

DRUG

Ephedrine

"Ephedrine will be administered with conditions as below:~1. When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate \< 60 beats/min;~2. When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate \< 60 beats/min."

DEVICE

ADIVA System

"1. When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate \< 60 beats/min;~2. When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min;~3. When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min;~4. When SBP \< 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min."

DEVICE

DIVA System

"DIVA system works as below:~1. When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate \< 60 beats/min;~2. When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate \< 60 beats/min."

Trial Locations (1)

229899

KK Women's and Children's Hospital, Singapore

All Listed Sponsors
lead

KK Women's and Children's Hospital

OTHER_GOV

NCT03620942 - Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System | Biotech Hunter | Biotech Hunter