Clinical trial NCT06473818: Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section
Official title: Non-invasive vs Invasive Cardiac Output Monitoring in Patients Under Spinal Anesthesia During Cesarean Section: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodynamics
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cardiac output (CO)
timeFrame: 1-60 minutes after spinal anesthesia
measure: Cardiac index (CI)
timeFrame: 1-60 minutes after spinal anesthesia
measure: Stroke volume (SV)
timeFrame: 1-60 minutes after spinal anesthesia
measure: Stroke volume variation (SVV)
timeFrame: 1-60 minutes after spinal anesthesia
measure: Peripheral vascular resistance
timeFrame: 1-60 minutes after spinal anesthesia
Secondary outcomes:
measure: The incidence of post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia.
measure: The incidence of severe post-spinal anesthesia hypotension
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of bradycardia
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of nausea and vomiting.
timeFrame: 1-15 minutes after spinal anesthesia
measure: The incidence of hypertension
timeFrame: 1-15 minutes after spinal anesthesia
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Yi Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: