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Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Locations
China
Study Type
Observational
Intervention
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Coronary Artery Disease focused on measuring CAD, CABG, CO, CI, thermodilution, USCOM

Eligibility Criteria

42 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • society of emergency medicine of C.M.A

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

CABG,general anesthesia

group 1

Arm Description

their CO and CI was measured with USCOM and Swan-ganz cco respectively.

co measured with swan-ganz cco combined with vigilance

Outcomes

Primary Outcome Measures

All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006

Secondary Outcome Measures

All 18 post-CABG coronary artery disease patients receiving treatment in the SCCU of Beijing Chaoyang Hospital from March to July 2006

Full Information

First Posted
December 5, 2008
Last Updated
December 8, 2008
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00804778
Brief Title
Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output
Official Title
Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output in Patients With Coronary Artery Bypass Grafting
Study Type
Observational

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, CABG, CO, CI, thermodilution, USCOM

7. Study Design

Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG,general anesthesia
Arm Description
their CO and CI was measured with USCOM and Swan-ganz cco respectively.
Arm Title
group 1
Arm Description
co measured with swan-ganz cco combined with vigilance
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Study Population 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.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.
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chunsheng li, professor
Organizational Affiliation
society of emergency medicine of C.M.A
Official's Role
Principal Investigator
Facility Information:
Facility Name
society of emergency medicine of C.M.A
City
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15728064
Citation
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.
Results Reference
background
PubMed Identifier
16750729
Citation
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.
Results Reference
background

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Comparison of USCOM Cardiac Output and Continuous Thermodilution Cardiac Output

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