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NCT Number: NCT06473818

Non-invasive vs Invasive Cardiac Output Monitoring 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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Key information

Conditions

Hemodynamics

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive monitoring

Device

Non-invasive cardiac output monitoring

Other names: Hemodynamics

Invasive monitoring

Device

Invasive cardiac output monitoring

Other names: hemodynamics

Primary outcomes

  1. Cardiac output (CO)

    Time frame: 1-60 minutes after spinal anesthesia

    Monitoring data

  2. Cardiac index (CI)

    Time frame: 1-60 minutes after spinal anesthesia

    Monitoring data

  3. Stroke volume (SV)

    Time frame: 1-60 minutes after spinal anesthesia

    Monitoring data

  4. Stroke volume variation (SVV)

    Time frame: 1-60 minutes after spinal anesthesia

    Monitoring data

  5. Peripheral vascular resistance

    Time frame: 1-60 minutes after spinal anesthesia

    Monitoring data

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia.

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

  2. The incidence of severe post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

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

  3. The incidence of bradycardia

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 60 beats/min

  4. The incidence of nausea and vomiting.

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of hypertension

    Time frame: 1-15 minutes after spinal anesthesia

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

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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