Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

General Hospital of Ningxia Medical University

Status: Not yet enrolling

Conditions: Hemodynamics

Treatments: Device: Invasive monitoring; Device: Non-invasive monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06473818

Yi Chen-2024-13

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Normotensive pregnant women

Description:

Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia

Treatment:

Device: Non-invasive monitoring

Device: Invasive monitoring