HemodynamicsNCT06473818
Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section
An observational study of Hemodynamics, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Non-invasive monitoring and Invasive monitoring
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 21 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: 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).
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).
- Conditions
- Hemodynamics
- Being tested
- Non-invasive monitoring, Invasive monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive monitoringDevice
Also called Hemodynamics
Non-invasive cardiac output monitoring
Invasive monitoringDevice
Also called hemodynamics
Invasive cardiac output monitoring
| Study group | Role | What they receive |
|---|---|---|
| Normotensive pregnant women | Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia Receives: Device: Non-invasive monitoring; Device: Invasive monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (CO)
Monitoring data
Measured: 1-60 minutes after spinal anesthesia
Cardiac index (CI)
Monitoring data
Measured: 1-60 minutes after spinal anesthesia
Stroke volume (SV)
Monitoring data
Measured: 1-60 minutes after spinal anesthesia
Stroke volume variation (SVV)
Monitoring data
Measured: 1-60 minutes after spinal anesthesia
Peripheral vascular resistance
Monitoring data
Measured: 1-60 minutes after spinal anesthesia
Secondary outcomes (5)
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
Measured: 1-15 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 60% of the baseline
Measured: 1-15 minutes after spinal anesthesia
The incidence of bradycardia
Heart rate < 60 beats/min
Measured: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Measured: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Systolic blood pressure (SBP) >120% of the baseline
Measured: 1-15 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Nov 2025
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Chen, M.D., Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473818
- Sponsor's protocol ID
- Yi Chen-2024-13
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi Y, Ma Y, Cun J, Yu X, Chen Y. Agreement and trending ability between non-invasive and invasive hemodynamic monitoring during cesarean section under spinal anesthesia: a prospective observational study. Front Med (Lausanne). 2026 Jul 29;13:1870822. doi: 10.3389/fmed.2026.1870822. eCollection 2026.
PubMed 42591555
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive vs Invasive Cardiac Output Monitoring in Patients Under Spinal Anesthesia During Cesarean Section: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06473818
- Acronym / sponsor ID
- Yi Chen-2024-13
- Conditions
- Hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normotensive pregnant women | – | Device: Non-invasive monitoring, Device: Invasive monitoringSingleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive monitoringAlso: HemodynamicsNon-invasive cardiac output monitoring | Device | Normotensive pregnant women |
| Invasive monitoringAlso: hemodynamicsInvasive cardiac output monitoring | Device | Normotensive pregnant women |
Primary outcome
Cardiac output (CO)
Time frame: 1-60 minutes after spinal anesthesia
Monitoring data
Cardiac index (CI)
Time frame: 1-60 minutes after spinal anesthesia
Monitoring data
Stroke volume (SV)
Time frame: 1-60 minutes after spinal anesthesia
Monitoring data
Stroke volume variation (SVV)
Time frame: 1-60 minutes after spinal anesthesia
Monitoring data
Peripheral vascular resistance
Time frame: 1-60 minutes after spinal anesthesia
Monitoring data
5 secondary outcomes
The incidence of post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Time frame: 1-15 minutes after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42591555Shi Y, Ma Y, Cun J, Yu X, Chen Y. Agreement and trending ability between non-invasive and invasive hemodynamic monitoring during cesarean section under spinal anesthesia: a prospective observational study. Front Med (Lausanne). 2026 Jul 29;13:1870822. doi: 10.3389/fmed.2026.1870822. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Chen, M.D. principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (CO) (time frame: 1-60 minutes after spinal anesthesia). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.