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CompletedNCT06473818Updated May 1, 2026

Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

An observational study in Hemodynamics, sponsored by General Hospital of Ningxia Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by General Hospital of Ningxia Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 45 Years
Sex
Female
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Study 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).

Read the 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).

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Conditions studied

  • Hemodynamics
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In context

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Device: Invasive monitoring

Interventions

  • DeviceNon-invasive monitoring

    Non-invasive cardiac output monitoring

    Also known as: Hemodynamics

  • DeviceInvasive monitoring

    Invasive cardiac output monitoring

    Also known as: hemodynamics

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What researchers measure

Primary outcomes

  1. Cardiac output (CO)

    Monitoring data

    Time frame: 1-60 minutes after spinal anesthesia

  2. Cardiac index (CI)

    Monitoring data

    Time frame: 1-60 minutes after spinal anesthesia

  3. Stroke volume (SV)

    Monitoring data

    Time frame: 1-60 minutes after spinal anesthesia

  4. Stroke volume variation (SVV)

    Monitoring data

    Time frame: 1-60 minutes after spinal anesthesia

  5. Peripheral vascular resistance

    Monitoring data

    Time frame: 1-60 minutes after spinal anesthesia

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) \< 80% of the baseline

    Time frame: 1-15 minutes after spinal anesthesia.

  2. The incidence of severe post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) \< 60% of the baseline

    Time frame: 1-15 minutes after spinal anesthesia

  3. The incidence of bradycardia

    Heart rate \< 60 beats/min

    Time frame: 1-15 minutes after spinal anesthesia

  4. The incidence of nausea and vomiting.

    Presence of nausea and vomiting in patients after spinal anesthesia

    Time frame: 1-15 minutes after spinal anesthesia

  5. The incidence of hypertension

    Systolic blood pressure (SBP) \>120% of the baseline

    Time frame: 1-15 minutes after spinal anesthesia

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Study locations

1 site
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06473818
Lead sponsor
General Hospital of Ningxia Medical University
Responsible party
Sponsor
First posted
Jun 25, 2024
Start date
Nov 1, 2025
Primary completion
Jan 21, 2026
Completion
Jan 21, 2026
Last update
May 1, 2026

Study contacts

Yi Chen, M.D.
principal investigator · General Hospital of Ningxia Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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