Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section
- Conditions
- Hemodynamics
- Registration Number
- NCT06473818
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).
- Detailed Description
The uterine placenta lacks autonomous regulatory ability, thus making maternal cardiac output (CO) the primary source of blood supply. Therefore, monitoring hemodynamics, including maternal CO, is of significant importance and provides guidance for anesthesia decisions such as fluid management and the administration of vasopressors during cesarean section. This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥37 weeks
- American Society of Anesthesiologists physical status classification I to II
- Scheduled for cesarean section under spinal anesthesia
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac output (CO) 1-60 minutes after spinal anesthesia Monitoring data
Cardiac index (CI) 1-60 minutes after spinal anesthesia Monitoring data
Stroke volume variation (SVV) 1-60 minutes after spinal anesthesia Monitoring data
Stroke volume (SV) 1-60 minutes after spinal anesthesia Monitoring data
Peripheral vascular resistance 1-60 minutes after spinal anesthesia Monitoring data
- Secondary Outcome Measures
Name Time Method The incidence of severe post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \< 60% of the baseline
The incidence of bradycardia 1-15 minutes after spinal anesthesia Heart rate \< 60 beats/min
The incidence of nausea and vomiting. 1-15 minutes after spinal anesthesia Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \>120% of the baseline
The incidence of post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 80% of the baseline