Clinical trial NCT04752904: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Hypotension
Keywords: noninvasive continuous blood pressure monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 154
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind controlled trial
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Incidence of hypotension by individualized methods
timeFrame: From spinal anesthesia to delivery
Secondary outcomes:
measure: Incidence of hypotension by standard methods
timeFrame: From spinal anesthesia to delivery
measure: Time-weighted average SBP<80% of baseline SBP
timeFrame: From spinal anesthesia to delivery
measure: Time-weighted average MAP <65mmHg
timeFrame: From spinal anesthesia to delivery
measure: Incidence of intraoperative severe hypotension
timeFrame: From spinal anesthesia to delivery
measure: Incidence of intraoperative symptomatic hypotension
timeFrame: From spinal anesthesia to delivery
measure: Incidence of nausea, vomiting, dizziness, breathlessness
timeFrame: From spinal anesthesia to delivery
measure: Incidence of intraoperative Hypertension
timeFrame: From spinal anesthesia to delivery
measure: Maximum, Minimum recorded SBP, DBP, MBP
timeFrame: From spinal anesthesia to delivery
measure: Cumulative duration of hypotension
timeFrame: From spinal anesthesia to delivery
measure: Number of hypotensive episodes
timeFrame: From spinal anesthesia to delivery
measure: Onset time of hypotension
timeFrame: From spinal anesthesia to delivery
measure: Cumulative consumptions of vasopressors
timeFrame: From spinal anesthesia to delivery
measure: Incidence of bradycardia
timeFrame: From spinal anesthesia to delivery
measure: Incidence of atropine use
timeFrame: From spinal anesthesia to delivery
measure: Minimum heart rate
timeFrame: From spinal anesthesia to delivery
measure: Cardiac output, stroke volume
timeFrame: From spinal anesthesia to delivery
measure: The analysis of the differences between the test method (ClearSight) and reference method
timeFrame: From spinal anesthesia to delivery
measure: Apgar Score
timeFrame: at 1 minute after delivery and 5 minutes after delivery
measure: Umbilical arterial blood
timeFrame: within 10 minutes after delivery
measure: Umbilical arterial pH
timeFrame: within 10 minutes after delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sun-Kyung Park, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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