Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

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

Detailed Description
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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

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

Conditions
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Cesarean Section Complications, Hypotension

Intervention / Treatment
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* Device: ClearSight System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized double blind controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ClearSight group<br>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<br>* Non-invasive, continuous blood pressure is monitored using ClearSight Sytem<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension by individualized methods | Hypotension was defined as: SBP<80% of baseline SBP | From spinal anesthesia to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension by standard methods | Hypotension was defined as MBP<65mmHg | From spinal anesthesia to delivery | 
| Time-weighted average SBP<80% of baseline SBP | Time-weighted average SBP<80% of baseline SBP | From spinal anesthesia to delivery | 
| Time-weighted average MAP <65mmHg | Time-weighted average MAP <65mmHg | From spinal anesthesia to delivery | 
| Incidence of intraoperative severe hypotension | Defined as: SBP < 70% of baseline SBP | From spinal anesthesia to delivery | 
| Incidence of intraoperative symptomatic hypotension | 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 | Incidence of nausea, vomiting, dizziness, breathlessness | From spinal anesthesia to delivery | 
| Incidence of intraoperative Hypertension | SBP> 120% of baseline SBP | From spinal anesthesia to delivery | 
| Maximum, Minimum recorded SBP, DBP, MBP | Maximum, Minimum recorded SBP, DBP, MBP | From spinal anesthesia to delivery | 
| Cumulative duration of hypotension | Cumulative duration of hypotension | From spinal anesthesia to delivery | 
| Number of hypotensive episodes | Number of hypotensive episodes | From spinal anesthesia to delivery | 
| Onset time of hypotension | Onset time of hypotension | From spinal anesthesia to delivery | 
| Cumulative consumptions of vasopressors | Cumulative consumptions of vasopressors | From spinal anesthesia to delivery | 
| Incidence of bradycardia | HR (heart rate) <50 bpm | From spinal anesthesia to delivery | 
| Incidence of atropine use | Incidence of atropine use | From spinal anesthesia to delivery | 
| Minimum heart rate | Minimum heart rate | From spinal anesthesia to delivery | 
| Cardiac output, stroke volume | only in ClearSight System group | From spinal anesthesia to delivery | 
| The analysis of the differences between the test method (ClearSight) and reference method | Bland-Altman analysis | From spinal anesthesia to delivery | 
| Apgar Score | 1 minute, 5 minutes | at 1 minute after delivery and 5 minutes after delivery | 
| Umbilical arterial blood | Arterial blood gas analysis results | within 10 minutes after delivery | 
| Umbilical arterial pH | <7.2 | within 10 minutes after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive continuous blood pressure monitoring