Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Not Applicable

Completed

• Conditions: Hypotension; Cesarean Section Complications
• Interventions: Device: ClearSight System

• Registration Number: NCT04752904
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Study Start: 2021-04-27
• Primary Completion: 2022-10-26
• Status Verified: 2022-12
• Study Completion: 2022-12-21
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ClearSight group	ClearSight System	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.

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension by individualized methods	From spinal anesthesia to delivery	Hypotension was defined as: SBP\<80% of baseline SBP

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of