Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

Non-invasive vs Invasive Cardiac Output Monitoring in Patients Under Spinal Anesthesia During Cesarean Section: a Prospective Observational Study

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 Overview

• Status: Completed
• Conditions: Hemodynamics
• Intervention / Treatment: Device: Non-invasive monitoring; Device: Invasive monitoring

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normotensive pregnant women; Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia	Device: Non-invasive monitoring; Non-invasive cardiac output monitoring; Other Names: Hemodynamics; Device: Invasive monitoring; Invasive cardiac output monitoring; Other Names: hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output (CO)	Monitoring data	1-60 minutes after spinal anesthesia
Cardiac index (CI)	Monitoring data	1-60 minutes after spinal anesthesia
Stroke volume (SV)	Monitoring data	1-60 minutes after spinal anesthesia
Stroke volume variation (SVV)	Monitoring data	1-60 minutes after spinal anesthesia
Peripheral vascular resistance	Monitoring data	1-60 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 60% of the baseline	1-15 minutes after spinal anesthesia
The incidence of bradycardia	Heart rate < 60 beats/min	1-15 minutes after spinal anesthesia
The incidence of hypertension	Systolic blood pressure (SBP) >120% of the baseline	1-15 minutes after spinal anesthesia
The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia.

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: Yi Chen, M.D., General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): January 21, 2026
• Study Completion (Actual): January 21, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Yi Chen-2024-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No