Cesarean Section Complications, Hypotension
Conditions
Keywords
noninvasive continuous blood pressure monitoring
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
Interventions
DEVICEClearSight System
Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
randomized double blind controlled trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotension by individualized methods | From spinal anesthesia to delivery | Hypotension was defined as: SBP\<80% of baseline SBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotension by standard methods | From spinal anesthesia to delivery | Hypotension was defined as MBP\<65mmHg |
| Time-weighted average SBP<80% of baseline SBP | From spinal anesthesia to delivery | Time-weighted average SBP\<80% of baseline SBP |
| Time-weighted average MAP <65mmHg | From spinal anesthesia to delivery | Time-weighted average MAP \<65mmHg |
| 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 |
| Incidence of intraoperative Hypertension | From spinal anesthesia to delivery | SBP\> 120% of baseline SBP |
| Maximum, Minimum recorded SBP, DBP, MBP | From spinal anesthesia to delivery | Maximum, Minimum recorded SBP, DBP, MBP |
| Cumulative duration of hypotension | From spinal anesthesia to delivery | Cumulative duration of hypotension |
| Number of hypotensive episodes | From spinal anesthesia to delivery | Number of hypotensive episodes |
| Incidence of intraoperative severe hypotension | From spinal anesthesia to delivery | Defined as: SBP \< 70% of baseline SBP |
| Cumulative consumptions of vasopressors | From spinal anesthesia to delivery | Cumulative consumptions of vasopressors |
| Incidence of bradycardia | From spinal anesthesia to delivery | HR (heart rate) \<50 bpm |
| Incidence of atropine use | From spinal anesthesia to delivery | Incidence of atropine use |
| Minimum heart rate | From spinal anesthesia to delivery | Minimum heart rate |
| Cardiac output, stroke volume | From spinal anesthesia to delivery | only in ClearSight System group |
| The analysis of the differences between the test method (ClearSight) and reference method | From spinal anesthesia to delivery | Bland-Altman analysis |
| 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 |
| Onset time of hypotension | From spinal anesthesia to delivery | Onset time of hypotension |
Countries
South Korea
Outcome results
None listed