Pulmonary Arterial HypertensionNCT05587400
Consistency of Electrical Cardiometry and Pulmonary Artery Catheter
A study testing passive leg raising, dobutamine test and inhaled nitric oxide in people with Pulmonary Arterial Hypertension and Right Ventricular Dysfunction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Right Ventricular Dysfunction
- What is being tested?
- passive leg raising, dobutamine test and inhaled nitric oxide
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 31 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult cardiac surgery patients
- pulmonary artery hypertension and/or right heart dysfunction
- mechanical ventilation
Who cannot join
- life threatening arrhythmia
- severe valve regurgitation
- left ventricular ejection fraction less than 30%
- patients with mechanical circulatory support
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Guo-wei Tu, PhD, 64041990 ext. 2923, tu.guowei@zs-hospital.sh.cn
About this study
Official title: The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart Dysfunction
Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. By measuring the thoracic electrical bioimpedance, electrical cardiometry (EC) technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, in patients with pulmonary arterial hypertension (PAH) and/or right ventricular (RV) dysfunction, few study has been reported. The aim of this study is to evaluate the agreement between CO measured by PAC as the referenced method and CO measured by EC technique in patients with PAH and/or RV dysfunction.
- Being tested
- passive leg raising, dobutamine test, inhaled nitric oxide
- Medical subject headings
- Pulmonary Arterial Hypertension, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raisingBehavioural
transfer a patient from semi-recumbent position to supine position with a 45° leg lifting
dobutamine testDrug
infusion dobutamine
inhaled nitric oxideDrug
nitric oxide inhalation
| Study group | Role | What they receive |
|---|---|---|
| patients with pulmonary artery hypertension and/or right ventricular dysfunction | Experimental | Not described Receives: Behavioral: passive leg raising; Drug: dobutamine test; Drug: inhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 5minutes after the patients was sedated
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 5minutes after the patients was sedated
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 2 minutes after passive leg raising
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 2 minutes after passive leg raising
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 15 minutes after termination of passive leg raising
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 15 minutes after termination of passive leg raising
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 30 minutes after dobutamine infusion
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 30 minutes after dobutamine infusion
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 30 minutes after termination of dobutamine infusion
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 30 minutes after termination of dobutamine infusion
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
Measured: 30 minutes after nitric oxide inhalation
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
Measured: 30 minutes after nitric oxide inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start27 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guang-wei Hao, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587400
- Sponsor's protocol ID
- COMEEC
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart Dysfunction
- ClinicalTrials.gov ID
- NCT05587400
- Acronym / sponsor ID
- COMEEC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Oct 2022 (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.
Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. By measuring the thoracic electrical bioimpedance, electrical cardiometry (EC) technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, in patients with pulmonary arterial hypertension (PAH) and/or right ventricular (RV) dysfunction, few study has been reported. The aim of this study is to evaluate the agreement between CO measured by PAC as the referenced method and CO measured by EC technique in patients with PAH and/or RV dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with pulmonary artery hypertension and/or right ventricular dysfunction | Experimental | Behavioral: passive leg raising, Drug: dobutamine test, Drug: inhaled nitric oxide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult cardiac surgery patients
- pulmonary artery hypertension and/or right heart dysfunction
- mechanical ventilation
Key exclusion criteria (4 listed)
- life threatening arrhythmia
- severe valve regurgitation
- left ventricular ejection fraction less than 30%
- patients with mechanical circulatory support
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 |
|---|---|---|
| passive leg raisingtransfer a patient from semi-recumbent position to supine position with a 45° leg lifting | Behavioural | patients with pulmonary artery hypertension and/or right ventricular dysfunction |
| dobutamine testinfusion dobutamine | Drug | patients with pulmonary artery hypertension and/or right ventricular dysfunction |
| inhaled nitric oxidenitric oxide inhalation | Drug | patients with pulmonary artery hypertension and/or right ventricular dysfunction |
Primary outcome
cardiac output by pulmonary artery catheter
Time frame: 5minutes after the patients was sedated
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 5minutes after the patients was sedated
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
Time frame: 2 minutes after passive leg raising
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 2 minutes after passive leg raising
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
Time frame: 15 minutes after termination of passive leg raising
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 15 minutes after termination of passive leg raising
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
Time frame: 30 minutes after dobutamine infusion
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 30 minutes after dobutamine infusion
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
Time frame: 30 minutes after termination of dobutamine infusion
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 30 minutes after termination of dobutamine infusion
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
Time frame: 30 minutes after nitric oxide inhalation
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
Time frame: 30 minutes after nitric oxide inhalation
measuring cardiac output using electrical cardiometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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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.
Guang-wei Hao, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive leg raising, dobutamine test and inhaled nitric oxide in people with Pulmonary Arterial Hypertension and Right Ventricular Dysfunction, run by Shanghai Zhongshan Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Luo, PhD (02164041990 ext. 3659, luo.zhe@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac output by pulmonary artery catheter (time frame: 5minutes after the patients was sedated). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.