Trial Outcomes & Findings for Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM) (NCT NCT00924482)

Results Overview

Correlation measured via Linear regression between thermodilution and ECOM, included as r\^2 coefficient. Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient. ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

261 participants

Primary outcome timeframe

perioperative period

Results posted on

2023-11-28

Participant Flow

Cardiac output measurements were made in adult patients undergoing cardiac surgery at the San Francisco VA Medical Center. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.

Design of the ECOM system and algorithm as well as safety testing were done using an animal model. The initial participants were used to finalize the system and model of the relationship between true and impedance-derived measurement of cardiac output. The final algorithm and electronics were tested in the last 101 enrolled participants.

Participant milestones

Participant milestones
Measure	Adult Cardiac Surgery Patients Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement. Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.
Overall Study STARTED	261
Overall Study COMPLETED	261
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Cardiac Surgery Patients n=101 Participants Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement. Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements. Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants
Weight	91 kg STANDARD_DEVIATION 19 • n=5 Participants
Height	175 cm STANDARD_DEVIATION 8 • n=5 Participants
Body Surface Area	2.1 meters^2 STANDARD_DEVIATION 0.2 • n=5 Participants
Ejection Fraction	56 percent STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: perioperative period

Population: Results are for the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were made during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.

Correlation measured via Linear regression between thermodilution and ECOM, included as r\^2 coefficient. Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient. ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely).

Outcome measures

Outcome measures
Measure	Adult Cardiac Surgery Patients n=101 Participants Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement. Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements. Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.
Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements	0.31 liters/min Standard Deviation 1.02

SECONDARY outcome

Timeframe: perioperative period

Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements

Outcome measures

Outcome measures
Measure	Adult Cardiac Surgery Patients n=261 Participants Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement. Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements. Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.
Safety of Device Measured by Number of Participants With Adverse Events	0 participants

Adverse Events

Adult Cardiac Surgery Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arthur Wallace, M.D., Ph.D.

University of California San Francisco

Phone: 415-750-2069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place