MedTrace Logo

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

NCT04025918 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2019-07-19

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Ban Leong Sng, FANZCA · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025918 on ClinicalTrials.gov