Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section

NCT06473818 | Completed

• 1 other identifier: Yi Chen-2024-13
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• The incidence of post-spinal anesthesia hypotension

  1-15 minutes after spinal anesthesia.

• The incidence of severe post-spinal anesthesia hypotension

  1-15 minutes after spinal anesthesia

• The incidence of bradycardia

  1-15 minutes after spinal anesthesia

• The incidence of nausea and vomiting.

  1-15 minutes after spinal anesthesia

• The incidence of hypertension

  1-15 minutes after spinal anesthesia

Study Arms (1)

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

Non-invasive monitoring DEVICE

Non-invasive cardiac output monitoring

Also known as: Hemodynamics

Normotensive pregnant women

Invasive monitoring DEVICE

Invasive cardiac output monitoring

Also known as: hemodynamics

Normotensive pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Study Officials

• Yi Chen, M.D.

  General Hospital of Ningxia Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: November 1, 2025
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)