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Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Primary Purpose

Cesarean Section Complications, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ClearSight System
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring noninvasive continuous blood pressure monitoring

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ClearSight group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Incidence of hypotension by individualized methods
Hypotension was defined as: SBP<80% of baseline SBP

Secondary Outcome Measures

Incidence of hypotension by standard methods
Hypotension was defined as MBP<65mmHg
Time-weighted average SBP<80% of baseline SBP
Time-weighted average SBP<80% of baseline SBP
Time-weighted average MAP <65mmHg
Time-weighted average MAP <65mmHg
Incidence of intraoperative severe hypotension
Defined as: SBP < 70% of baseline SBP
Incidence of intraoperative symptomatic hypotension
Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
Incidence of nausea, vomiting, dizziness, breathlessness
Incidence of nausea, vomiting, dizziness, breathlessness
Incidence of intraoperative Hypertension
SBP> 120% of baseline SBP
Maximum, Minimum recorded SBP, DBP, MBP
Maximum, Minimum recorded SBP, DBP, MBP
Cumulative duration of hypotension
Cumulative duration of hypotension
Number of hypotensive episodes
Number of hypotensive episodes
Onset time of hypotension
Onset time of hypotension
Cumulative consumptions of vasopressors
Cumulative consumptions of vasopressors
Incidence of bradycardia
HR (heart rate) <50 bpm
Incidence of atropine use
Incidence of atropine use
Minimum heart rate
Minimum heart rate
Cardiac output, stroke volume
only in ClearSight System group
The analysis of the differences between the test method (ClearSight) and reference method
Bland-Altman analysis
Apgar Score
1 minute, 5 minutes
Umbilical arterial blood
Arterial blood gas analysis results
Umbilical arterial pH
<7.2

Full Information

First Posted
February 5, 2021
Last Updated
December 26, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04752904
Brief Title
Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery
Official Title
Noninvasive Continuous Blood Pressure Monitoring for Preventing Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Hypotension
Keywords
noninvasive continuous blood pressure monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized double blind controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClearSight group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
ClearSight System
Intervention Description
Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
Primary Outcome Measure Information:
Title
Incidence of hypotension by individualized methods
Description
Hypotension was defined as: SBP<80% of baseline SBP
Time Frame
From spinal anesthesia to delivery
Secondary Outcome Measure Information:
Title
Incidence of hypotension by standard methods
Description
Hypotension was defined as MBP<65mmHg
Time Frame
From spinal anesthesia to delivery
Title
Time-weighted average SBP<80% of baseline SBP
Description
Time-weighted average SBP<80% of baseline SBP
Time Frame
From spinal anesthesia to delivery
Title
Time-weighted average MAP <65mmHg
Description
Time-weighted average MAP <65mmHg
Time Frame
From spinal anesthesia to delivery
Title
Incidence of intraoperative severe hypotension
Description
Defined as: SBP < 70% of baseline SBP
Time Frame
From spinal anesthesia to delivery
Title
Incidence of intraoperative symptomatic hypotension
Description
Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
Time Frame
From spinal anesthesia to delivery
Title
Incidence of nausea, vomiting, dizziness, breathlessness
Description
Incidence of nausea, vomiting, dizziness, breathlessness
Time Frame
From spinal anesthesia to delivery
Title
Incidence of intraoperative Hypertension
Description
SBP> 120% of baseline SBP
Time Frame
From spinal anesthesia to delivery
Title
Maximum, Minimum recorded SBP, DBP, MBP
Description
Maximum, Minimum recorded SBP, DBP, MBP
Time Frame
From spinal anesthesia to delivery
Title
Cumulative duration of hypotension
Description
Cumulative duration of hypotension
Time Frame
From spinal anesthesia to delivery
Title
Number of hypotensive episodes
Description
Number of hypotensive episodes
Time Frame
From spinal anesthesia to delivery
Title
Onset time of hypotension
Description
Onset time of hypotension
Time Frame
From spinal anesthesia to delivery
Title
Cumulative consumptions of vasopressors
Description
Cumulative consumptions of vasopressors
Time Frame
From spinal anesthesia to delivery
Title
Incidence of bradycardia
Description
HR (heart rate) <50 bpm
Time Frame
From spinal anesthesia to delivery
Title
Incidence of atropine use
Description
Incidence of atropine use
Time Frame
From spinal anesthesia to delivery
Title
Minimum heart rate
Description
Minimum heart rate
Time Frame
From spinal anesthesia to delivery
Title
Cardiac output, stroke volume
Description
only in ClearSight System group
Time Frame
From spinal anesthesia to delivery
Title
The analysis of the differences between the test method (ClearSight) and reference method
Description
Bland-Altman analysis
Time Frame
From spinal anesthesia to delivery
Title
Apgar Score
Description
1 minute, 5 minutes
Time Frame
at 1 minute after delivery and 5 minutes after delivery
Title
Umbilical arterial blood
Description
Arterial blood gas analysis results
Time Frame
within 10 minutes after delivery
Title
Umbilical arterial pH
Description
<7.2
Time Frame
within 10 minutes after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Kyung Park, M.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31977628
Citation
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Results Reference
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Results Reference
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PubMed Identifier
31531852
Citation
Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
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PubMed Identifier
30267340
Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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32682556
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Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

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