Skip to main content
OpenTrials
Completed

NCT Number: NCT04752904

Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Complications Cardiovascular Diseases Hypotension Vascular Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClearSight System

Device

Non-invasive, continuous blood pressure is monitored using ClearSight Sytem

Primary outcomes

  1. Incidence of hypotension by individualized methods

    Time frame: From spinal anesthesia to delivery

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

Secondary outcomes

  1. Incidence of hypotension by standard methods

    Time frame: From spinal anesthesia to delivery

    Hypotension was defined as MBP<65mmHg

  2. Time-weighted average SBP<80% of baseline SBP

    Time frame: From spinal anesthesia to delivery

    Time-weighted average SBP<80% of baseline SBP

  3. Time-weighted average MAP <65mmHg

    Time frame: From spinal anesthesia to delivery

    Time-weighted average MAP <65mmHg

  4. Incidence of intraoperative severe hypotension

    Time frame: From spinal anesthesia to delivery

    Defined as: SBP < 70% of baseline SBP

  5. Incidence of intraoperative symptomatic hypotension

    Time frame: From spinal anesthesia to delivery

    Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness

  6. Incidence of nausea, vomiting, dizziness, breathlessness

    Time frame: From spinal anesthesia to delivery

    Incidence of nausea, vomiting, dizziness, breathlessness

  7. Incidence of intraoperative Hypertension

    Time frame: From spinal anesthesia to delivery

    SBP> 120% of baseline SBP

  8. Maximum, Minimum recorded SBP, DBP, MBP

    Time frame: From spinal anesthesia to delivery

    Maximum, Minimum recorded SBP, DBP, MBP

  9. Cumulative duration of hypotension

    Time frame: From spinal anesthesia to delivery

    Cumulative duration of hypotension

  10. Number of hypotensive episodes

    Time frame: From spinal anesthesia to delivery

    Number of hypotensive episodes

  11. Onset time of hypotension

    Time frame: From spinal anesthesia to delivery

    Onset time of hypotension

  12. Cumulative consumptions of vasopressors

    Time frame: From spinal anesthesia to delivery

    Cumulative consumptions of vasopressors

  13. Incidence of bradycardia

    Time frame: From spinal anesthesia to delivery

    HR (heart rate) <50 bpm

  14. Incidence of atropine use

    Time frame: From spinal anesthesia to delivery

    Incidence of atropine use

  15. Minimum heart rate

    Time frame: From spinal anesthesia to delivery

    Minimum heart rate

  16. Cardiac output, stroke volume

    Time frame: From spinal anesthesia to delivery

    only in ClearSight System group

  17. The analysis of the differences between the test method (ClearSight) and reference method

    Time frame: From spinal anesthesia to delivery

    Bland-Altman analysis

  18. Apgar Score

    Time frame: at 1 minute after delivery and 5 minutes after delivery

    1 minute, 5 minutes

  19. Umbilical arterial blood

    Time frame: within 10 minutes after delivery

    Arterial blood gas analysis results

  20. Umbilical arterial pH

    Time frame: within 10 minutes after delivery

    <7.2

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.