Evaluating the Correction of Non-invasive Estimated Continuous Cardiac Output in Cardiac Surgical Patients

NCT01911117 | Withdrawn DMC

• 1 other identifier: A-ER-102-080
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In one previous study, esCCO was compared with continuous thermodilution CO (TDCO), measurements in 36 postoperative cardiac surgery patients, showing a bias (mean difference) of -0.06 and a precision (1 SD) of 0.82 L/min. In addition, esCCO was compared with intermittent bolus TDCO, showing a correlation coefficient of 0.82 (P \< 0.001, n = 24), a bias of -0.63, and a precision of 1.01 L/min (n = 119). The results of clinical use of esCCO suggest that its measurement accuracy is comparable to the thermodilution method in general population. However, no any intraoperative comparison for cardiac surgery patients was reported before. This study is designed for the accuracy in the patients undergoing cardiac surgery. Specific aims:

1. 1.To investigate the correlation of esCCO and the traditional CO measurement in cardiac surgical patients.
2. 2.To investigate the intraoperative t accuracy of time point between ecCCO and traditional CO measurement for patients undergoing bypass cardiac surgery.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• The correlation of esCCO and the traditional CO measurement in cardiac surgical patients.

  1. Comparison Between esCCO and Thermodilution Measurements of CO for cardiac surgical patients. 2. Check the accuracy of esCCO in cardiac surgical patients. It should be well correlated before bypass but will be inaccurate when partial bypass once start. When bypass procedure start to rewarm, it will be accurate initially but gradually well correlated within temperature corrected or heart function become normal again.

  18 months

Study Arms (1)

Cardiac Surgical Patients

Patients who undergo cardiac surgery will be included in this study. 1. Patients undergo cardiac surgery and are over 18 years of age. 2. Patients need bypass machine for their cardiac surgery and traditional CO measurement. 3. Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cardiac surgery will be included in this study.

You may qualify if:

• Patients undergo cardiac surgery and are over 18 years of age.
• Patients need bypass machine for their cardiac surgery and traditional CO measurement.
• Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements.

You may not qualify if:

• Patients are over 75 years of age. Patients are unable to read or write the informed consent, any condition that could interfere with the interpretation of outcome assessments, pregnant or lactating women. Patient with marked arrhythmias, those preoperatively receiving treatment with intra-aortic balloon bump (IABP) will also not be included.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Shengli Rd, 701, Taiwan

Location

Study Officials

• Yen-Chin Liu, Doctor

  Department of Anesthesiology, National Cheng-Kung University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Staff, Department of Anesthesiology Chief

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

TW (1)