Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
154
Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
Seoul National University Hospital
Seoul, South Korea
Incidence of hypotension by individualized methods
Hypotension was defined as: SBP\<80% of baseline SBP
Time frame: From spinal anesthesia to delivery
Incidence of hypotension by standard methods
Hypotension was defined as MBP\<65mmHg
Time frame: From spinal anesthesia to delivery
Time-weighted average SBP<80% of baseline SBP
Time-weighted average SBP\<80% of baseline SBP
Time frame: From spinal anesthesia to delivery
Time-weighted average MAP <65mmHg
Time-weighted average MAP \<65mmHg
Time frame: From spinal anesthesia to delivery
Incidence of intraoperative severe hypotension
Defined as: SBP \< 70% of baseline SBP
Time frame: From spinal anesthesia to delivery
Incidence of intraoperative symptomatic hypotension
Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
Time frame: From spinal anesthesia to delivery
Incidence of nausea, vomiting, dizziness, breathlessness
Incidence of nausea, vomiting, dizziness, breathlessness
Time frame: From spinal anesthesia to delivery
Incidence of intraoperative Hypertension
SBP\> 120% of baseline SBP
Time frame: From spinal anesthesia to delivery
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Maximum, Minimum recorded SBP, DBP, MBP
Maximum, Minimum recorded SBP, DBP, MBP
Time frame: From spinal anesthesia to delivery
Cumulative duration of hypotension
Cumulative duration of hypotension
Time frame: From spinal anesthesia to delivery
Number of hypotensive episodes
Number of hypotensive episodes
Time frame: From spinal anesthesia to delivery
Onset time of hypotension
Onset time of hypotension
Time frame: From spinal anesthesia to delivery
Cumulative consumptions of vasopressors
Cumulative consumptions of vasopressors
Time frame: From spinal anesthesia to delivery
Incidence of bradycardia
HR (heart rate) \<50 bpm
Time frame: From spinal anesthesia to delivery
Incidence of atropine use
Incidence of atropine use
Time frame: From spinal anesthesia to delivery
Minimum heart rate
Minimum heart rate
Time frame: From spinal anesthesia to delivery
Cardiac output, stroke volume
only in ClearSight System group
Time frame: From spinal anesthesia to delivery
The analysis of the differences between the test method (ClearSight) and reference method
Bland-Altman analysis
Time frame: From spinal anesthesia to delivery
Apgar Score
1 minute, 5 minutes
Time frame: at 1 minute after delivery and 5 minutes after delivery
Umbilical arterial blood
Arterial blood gas analysis results
Time frame: within 10 minutes after delivery
Umbilical arterial pH
\<7.2
Time frame: within 10 minutes after delivery