Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

December 26, 2022 updated by: Sun-Kyung Park, Seoul National University Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ClearSight group
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.
Device: ClearSight System
Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of hypotension by individualized methods
Time Frame: From spinal anesthesia to delivery
Hypotension was defined as: SBP<80% of baseline SBP
From spinal anesthesia to delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of hypotension by standard methods
Time Frame: From spinal anesthesia to delivery
Hypotension was defined as MBP<65mmHg
From spinal anesthesia to delivery
Time-weighted average SBP<80% of baseline SBP
Time Frame: From spinal anesthesia to delivery
Time-weighted average SBP<80% of baseline SBP
From spinal anesthesia to delivery
Time-weighted average MAP <65mmHg
Time Frame: From spinal anesthesia to delivery
Time-weighted average MAP <65mmHg
From spinal anesthesia to delivery
Incidence of intraoperative severe hypotension
Time Frame: From spinal anesthesia to delivery
Defined as: SBP < 70% of baseline SBP
From spinal anesthesia to delivery
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
From spinal anesthesia to delivery
Incidence of nausea, vomiting, dizziness, breathlessness
Time Frame: From spinal anesthesia to delivery
Incidence of nausea, vomiting, dizziness, breathlessness
From spinal anesthesia to delivery
Incidence of intraoperative Hypertension
Time Frame: From spinal anesthesia to delivery
SBP> 120% of baseline SBP
From spinal anesthesia to delivery
Maximum, Minimum recorded SBP, DBP, MBP
Time Frame: From spinal anesthesia to delivery
Maximum, Minimum recorded SBP, DBP, MBP
From spinal anesthesia to delivery
Cumulative duration of hypotension
Time Frame: From spinal anesthesia to delivery
Cumulative duration of hypotension
From spinal anesthesia to delivery
Number of hypotensive episodes
Time Frame: From spinal anesthesia to delivery
Number of hypotensive episodes
From spinal anesthesia to delivery
Onset time of hypotension
Time Frame: From spinal anesthesia to delivery
Onset time of hypotension
From spinal anesthesia to delivery
Cumulative consumptions of vasopressors
Time Frame: From spinal anesthesia to delivery
Cumulative consumptions of vasopressors
From spinal anesthesia to delivery
Incidence of bradycardia
Time Frame: From spinal anesthesia to delivery
HR (heart rate) <50 bpm
From spinal anesthesia to delivery
Incidence of atropine use
Time Frame: From spinal anesthesia to delivery
Incidence of atropine use
From spinal anesthesia to delivery
Minimum heart rate
Time Frame: From spinal anesthesia to delivery
Minimum heart rate
From spinal anesthesia to delivery
Cardiac output, stroke volume
Time Frame: From spinal anesthesia to delivery
only in ClearSight System group
From spinal anesthesia to delivery
The analysis of the differences between the test method (ClearSight) and reference method
Time Frame: From spinal anesthesia to delivery
Bland-Altman analysis
From spinal anesthesia to delivery
Apgar Score
Time Frame: at 1 minute after delivery and 5 minutes after delivery
1 minute, 5 minutes
at 1 minute after delivery and 5 minutes after delivery
Umbilical arterial blood
Time Frame: within 10 minutes after delivery
Arterial blood gas analysis results
within 10 minutes after delivery
Umbilical arterial pH
Time Frame: within 10 minutes after delivery
<7.2
within 10 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sun-Kyung Park, M.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-093-1165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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