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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • society of emergency medicine of C.M.A

    Beijing, 100020

Other trials in China

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.

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 groups in NCT00804778
Study groupRoleWhat they receive
CABG,general anesthesiatheir CO and CI was measured with USCOM and Swan-ganz cco respectively.
group 1co 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.

  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.

Secondary outcomes (1)
  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.

  1. First posted9 Dec 2008 (estimated)
  2. Study startMar 2006
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

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)
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 15728064
  • Chand 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

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.

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