Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

Not yet recruiting

• Conditions: Hemodynamics
• Interventions: Device: Non-invasive monitoring; Device: Invasive monitoring

• 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).

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normotensive pregnant women	Non-invasive monitoring	Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia
Normotensive pregnant women	Invasive monitoring	Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Stroke volume variation (SVV)	1-60 minutes after spinal anesthesia	Monitoring data
Cardiac output (CO)	1-60 minutes after spinal anesthesia	Monitoring data
Cardiac index (CI)	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