Coronary Artery DiseaseNCT00804778
Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output
An observational study of Coronary Artery Disease, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
It's reported that USCOM can be used to measured patients' CO and CI conveniently, accurately and not confined to place, because of it's no aggressive, it's accuracy is doubtful. Read more about this study
- Who is it for?
- Ages 42 to 78 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Jul 2006
- 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 42 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years.For all the patients after operation, pericardial cavity or left thorax close drainage, small tidal volume (6-8ml/kg) capacity controlled ventilation of breathing machine, appropriate pressure support (10-15cmH2O) and appropriate positive end-expiratory pressure were applied. Institutional ethics approval was obtained for the conduct of the trial.
Who may be able to join
- All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years.
Who cannot join
- Aortic regurgitation or stenosis was ruled out by preoperational color ultrasonic imaging, endocardiac shunt did not exist and there was no heart valve replacement in all the patients.
- Intra-aortic balloon pumping (IABP) was not used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output in Patients With Coronary Artery Bypass Grafting
It's reported that USCOM can be used to measured patients' CO and CI conveniently, accurately and not confined to place, because of it's no aggressive, it's accuracy is doubtful.
Read the detailed description
18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years. Aortic regurgitation or stenosis was ruled out by preoperational color ultrasonic imaging, endocardiac shunt did not exist and there was no heart valve replacement in all the patients. For all the patients after operation, pericardial cavity or left thorax close drainage, small tidal volume (6-8ml/kg) capacity controlled ventilation of breathing machine, appropriate pressure support (10-15cmH2O) and appropriate positive end-expiratory pressure were applied. Intra-aortic balloon pumping (IABP) was not used. Institutional ethics approval was obtained for the conduct of the trial.
All the patients received CABG under general anesthesia and non-extracorporeal circulation. Swan-Ganz CCO catheter (mbo 744HF75, USA) was set through right internal jugular vein or right subcalvian vein. The catheters were connected with VIGILANCE monitor after patients went back SCCU and the position of the catheters was adjusted. The bodyweight, height, instant heart rate, central venous pressure, invasive average aortic pressure and pulmonary wedge pressure of the patients were inputted into VIGILANCE monitor. VIGILANCE monitor automatically and intermittently displayed and saved the results of CO, CI, SVR, PVR and other hemodynamic parameters. VIGILANCE determined the hemodynamic parameters every 40-55seconds based on the signal noise ratio.
The period of USCOM monitoring time after CABG was 0.5-6hrs. Lowered the bed head and had the patients in horizontal position during the monitoring. Monitoring area was AV area. Turned on USCOM, selected AV mode, inputted the sex, height, bodyweight and birth date of the patients. Applied ultra transmission gel on the probe to let the probe contact the skin closely and let the probe point to the gluteal region nearly. USCOM screen automatically displayed the lateral border of the Doppler blood flow curve scanned with flow monitor and speaker displayed the acoustic signal of blood stream. The position, depth and direction of the probe were adjusted based on the figure signals and acoustic signals acquired with USCOM probe. Adjusted the sound volume, wave gain or contrast or turned the patient head gently. It indicated that the sound wave emitted by the probe had passed through aortic valve orifice or the root of aorta and the direction of sound beam paralleled to the blood flow through the aorta valve orifice when USCOM screen displayed maximum Doppler blood velocity wave and speaker displayed sharp and strong blood acoustic signals. The results were frozen and saved . Optimal measuring site, depth the probe was depressed down and direction of the probe were marked for the next measurement. Continuous 3-5 Doppler flow curves and the CO and CI measured on them were taken each time. The flow curves of one respiratory circle were taken for atrial fibrillation patients. For round probe, plane diameter was 1.5cm and frequency was 3.3MHz. The probe was disinfected with Iodophors each time before and after the measurement. The data of patient height, bodyweight and age, and operation duration was acquired from anesthesia note. CO time intervals measured with the two methods were about 2min. There was at least 30min interval between each pair of CO. Three to four pairs of CO and CI data were taken for each patient.
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, CABG, CO, CI, thermodilution, USCOM
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CABG,general anesthesia | their CO and CI was measured with USCOM and Swan-ganz cco respectively. | |
| group 1 | co measured with swan-ganz cco combined with vigilance |
What is being measured
The primary outcome is the main question the study is designed to answer.
All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006
Measured: The period of monitoring time after CABG was 0.5-6hrs.
Secondary outcomes (1)
All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006
Measured: The period of monitoring time after CABG was 0.5-6hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startMar 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Observational
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- chunsheng li, professor, Principal investigator, society of emergency medicine of C.M.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804778
- Sponsor's protocol ID
- chumingyidoc@sohu.com
- Other IDs
- lcscyyy@sohu.com
- Status last verified
- Dec 2008
- First submitted
- 5 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Critchley LA, Peng ZY, Fok BS, Lee A, Phillips RA. Testing the reliability of a new ultrasonic cardiac output monitor, the USCOM, by using aortic flowprobes in anesthetized dogs. Anesth Analg. 2005 Mar;100(3):748-753. doi: 10.1213/01.ANE.0000144774.42408.05.
PubMed 15728064Chand R, Mehta Y, Trehan N. Cardiac output estimation with a new Doppler device after off-pump coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2006 Jun;20(3):315-9. doi: 10.1053/j.jvca.2005.05.024. Epub 2006 Jan 18.
PubMed 16750729
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output in Patients With Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT00804778
- Acronym / sponsor ID
- chumingyidoc@sohu.com
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, CABG, CO, CI, thermodilution, USCOM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Dec 2008 (estimated)
- 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.
It's reported that USCOM can be used to measured patients' CO and CI conveniently, accurately and not confined to place, because of it's no aggressive, it's accuracy is doubtful.
Detailed description
18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years. Aortic regurgitation or stenosis was ruled out by preoperational color ultrasonic imaging, endocardiac shunt did not exist and there was no heart valve replacement in all the patients. For all the patients after operation, pericardial cavity or left thorax close drainage, small tidal volume (6-8ml/kg) capacity controlled ventilation of breathing machine, appropriate pressure support (10-15cmH2O) and appropriate positive end-expiratory pressure were applied. Intra-aortic balloon pumping (IABP) was not used. Institutional ethics approval was obtained for the conduct of the trial.
All the patients received CABG under general anesthesia and non-extracorporeal circulation. Swan-Ganz CCO catheter (mbo 744HF75, USA) was set through right internal jugular vein or right subcalvian vein. The catheters were connected with VIGILANCE monitor after patients went back SCCU and the position of the catheters was adjusted. The bodyweight, height, instant heart rate, central venous pressure, invasive average aortic pressure and pulmonary wedge pressure of the patients were inputted into VIGILANCE monitor. VIGILANCE monitor automatically and intermittently displayed and saved the results of CO, CI, SVR, PVR and other hemodynamic parameters. VIGILANCE determined the hemodynamic parameters every 40-55seconds based on the signal noise ratio.
The period of USCOM monitoring time after CABG was 0.5-6hrs. Lowered the bed head and had the patients in horizontal position during the monitoring. Monitoring area was AV area. Turned on USCOM, selected AV mode, inputted the sex, height, bodyweight and birth date of the patients. Applied ultra transmission gel on the probe to let the probe contact the skin closely and let the probe point to the gluteal region nearly. USCOM screen automatically displayed the lateral border of the Doppler blood flow curve scanned with flow monitor and speaker displayed the acoustic signal of blood stream. The position, depth and direction of the probe were adjusted based on the figure signals and acoustic signals acquired with USCOM probe. Adjusted the sound volume, wave gain or contrast or turned the patient head gently. It indicated that the sound wave emitted by the probe had passed through aortic valve orifice or the root of aorta and the direction of sound beam paralleled to the blood flow through the aorta valve orifice when USCOM screen displayed maximum Doppler blood velocity wave and speaker displayed sharp and strong blood acoustic signals. The results were frozen and saved . Optimal measuring site, depth the probe was depressed down and direction of the probe were marked for the next measurement. Continuous 3-5 Doppler flow curves and the CO and CI measured on them were taken each time. The flow curves of one respiratory circle were taken for atrial fibrillation patients. For round probe, plane diameter was 1.5cm and frequency was 3.3MHz. The probe was disinfected with Iodophors each time before and after the measurement. The data of patient height, bodyweight and age, and operation duration was acquired from anesthesia note. CO time intervals measured with the two methods were about 2min. There was at least 30min interval between each pair of CO. Three to four pairs of CO and CI data were taken for each patient.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG,general anesthesia | – | –their CO and CI was measured with USCOM and Swan-ganz cco respectively. |
| group 1 | – | –co measured with swan-ganz cco combined with vigilance |
Who may qualify
- Ages
- 42 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years.For all the patients after operation, pericardial cavity or left thorax close drainage, small tidal volume (6-8ml/kg) capacity controlled ventilation of breathing machine, appropriate pressure support (10-15cmH2O) and appropriate positive end-expiratory pressure were applied. Institutional ethics approval was obtained for the conduct of the trial.
Key inclusion criteria (1 listed)
- All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006, male (10) and female (8), with average age of 61.71士10.07 years.
Key exclusion criteria (2 listed)
- Aortic regurgitation or stenosis was ruled out by preoperational color ultrasonic imaging, endocardiac shunt did not exist and there was no heart valve replacement in all the patients.
- Intra-aortic balloon pumping (IABP) was not used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006
Time frame: The period of monitoring time after CABG was 0.5-6hrs.
1 secondary outcome
All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006
Time frame: The period of monitoring time after CABG was 0.5-6hrs.
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 9 Dec 2008.
- Background: PubMed 15728064Critchley LA, Peng ZY, Fok BS, Lee A, Phillips RA. Testing the reliability of a new ultrasonic cardiac output monitor, the USCOM, by using aortic flowprobes in anesthetized dogs. Anesth Analg. 2005 Mar;100(3):748-753. doi: 10.1213/01.ANE.0000144774.42408.05.
- Background: PubMed 16750729Chand R, Mehta Y, Trehan N. Cardiac output estimation with a new Doppler device after off-pump coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2006 Jun;20(3):315-9. doi: 10.1053/j.jvca.2005.05.024. Epub 2006 Jan 18.
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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.
chunsheng li, professor principal investigator
society of emergency medicine of C.M.A
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 Coronary Artery Disease, run by Beijing Chao Yang 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 1 inclusion and 2 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 9 Dec 2008. 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?
All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006 (time frame: The period of monitoring time after CABG was 0.5-6hrs.). 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 NCT00804778, which also lists 2 linked publications.
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 9 Dec 2008.