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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06473818
Enrollment
45
Registered
2024-06-25
Start date
2025-11-01
Completion date
2026-01-21
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics

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).

Interventions

DEVICENon-invasive monitoring

Non-invasive cardiac output monitoring

DEVICEInvasive monitoring

Invasive cardiac output monitoring

Sponsors

General Hospital of Ningxia Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output (CO)1-60 minutes after spinal anesthesiaMonitoring data
Cardiac index (CI)1-60 minutes after spinal anesthesiaMonitoring data
Stroke volume (SV)1-60 minutes after spinal anesthesiaMonitoring data
Stroke volume variation (SVV)1-60 minutes after spinal anesthesiaMonitoring data
Peripheral vascular resistance1-60 minutes after spinal anesthesiaMonitoring data

Secondary

MeasureTime frameDescription
The incidence of post-spinal anesthesia hypotension1-15 minutes after spinal anesthesia.Systolic blood pressure (SBP) \< 80% of the baseline
The incidence of severe post-spinal anesthesia hypotension1-15 minutes after spinal anesthesiaSystolic blood pressure (SBP) \< 60% of the baseline
The incidence of bradycardia1-15 minutes after spinal anesthesiaHeart rate \< 60 beats/min
The incidence of nausea and vomiting.1-15 minutes after spinal anesthesiaPresence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension1-15 minutes after spinal anesthesiaSystolic blood pressure (SBP) \>120% of the baseline

Countries

China

Contacts

PRINCIPAL_INVESTIGATORYi Chen, M.D.

General Hospital of Ningxia Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026