Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Seoul National University

Status: Completed

Conditions: Hypotension; Cesarean Section Complications

Treatments: Device: ClearSight System

Study type: Interventional

Funder types: Other

Identifiers

NCT04752904

2010-093-1165

Details and patient eligibility

About

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

Full 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

Enrollment: 154 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 2 patient groups

ClearSight group

Experimental group

Description:

Non-invasive, continuous blood pressure is monitored using ClearSight Sytem, with a finger cuff around the middle finger, and the anesthesiologist manages blood pressure based on this.

Treatment:

Device: ClearSight System

Control group

No Intervention group

Description:

The blood pressure is measured at 1-minute intervals by non-invasive blood pressure monitor using the arm cuff, and the anesthesiologist in charge manages the blood pressure based on the measured blood pressure.