Noninvasive Continuous Blood Pressure Monitoring for Preventing Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country154 target enrollmentApril 27, 2021

ConditionsCesarean Section Complications Hypotension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cesarean Section Complications
Sponsor: Seoul National University Hospital
Enrollment: 154
Locations: 1
Primary Endpoint: Incidence of hypotension by individualized methods
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial

Detailed Description

The aim of this study was to find out whether the incidence of hypotension during surgery can be reduced in the case of non-invasive, continuous blood pressure monitoring using the ClearSight System in patients undergoing cesarean section under spinal anesthesia, compared to the case of using conventional noninvasive blood pressure monitoring

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

December 21, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Sun-Kyung Park

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•Adult mothers who are pregnant with single fetuses over 35 weeks gestational age undergoing planned cesarean delivery under spinal anesthesia

Exclusion Criteria

•Multiple fetal pregnancy
•Preexisting hypertension or pregnancy-induced hypertension
•Underlying heart disease
•Underlying cerebrovascular disease
•Known fetal anomaly
•Contraindicated in spinal anesthesia
•Any sign of onset of labor
•Body weight \<45 kg or body weight\> 90 kg
•Height \<145cm or height\> 180cm
•All other cases in which researchers determine to be inappropriate for this clinical trial

Outcomes

Primary Outcomes

Incidence of hypotension by individualized methods

Time Frame: From spinal anesthesia to delivery

Hypotension was defined as: SBP\<80% of baseline SBP

Secondary Outcomes

Minimum heart rate(From spinal anesthesia to delivery)
Incidence of intraoperative severe hypotension(From spinal anesthesia to delivery)
Number of hypotensive episodes(From spinal anesthesia to delivery)
Incidence of intraoperative symptomatic hypotension(From spinal anesthesia to delivery)
Time-weighted average SBP<80% of baseline SBP(From spinal anesthesia to delivery)
Incidence of nausea, vomiting, dizziness, breathlessness(From spinal anesthesia to delivery)
Cumulative duration of hypotension(From spinal anesthesia to delivery)
Onset time of hypotension(From spinal anesthesia to delivery)
Incidence of bradycardia(From spinal anesthesia to delivery)
Apgar Score(at 1 minute after delivery and 5 minutes after delivery)
Umbilical arterial blood(within 10 minutes after delivery)
Umbilical arterial pH(within 10 minutes after delivery)
Incidence of hypotension by standard methods(From spinal anesthesia to delivery)
Time-weighted average MAP <65mmHg(From spinal anesthesia to delivery)
Incidence of intraoperative Hypertension(From spinal anesthesia to delivery)
Incidence of atropine use(From spinal anesthesia to delivery)
Cardiac output, stroke volume(From spinal anesthesia to delivery)
Maximum, Minimum recorded SBP, DBP, MBP(From spinal anesthesia to delivery)
Cumulative consumptions of vasopressors(From spinal anesthesia to delivery)
The analysis of the differences between the test method (ClearSight) and reference method(From spinal anesthesia to delivery)