Trial Outcomes & Findings for Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring. (NCT NCT03394768)

Last Updated: 2021-05-11

Results Overview

Comparison of cardiac output monitoring capabilities of the NICOM Cheetah® versus the FloTrac®. Cardiac output defined as the amount of blood the heart pumps through the circulatory system in a minute. Bland-Altman analysis used to compare the level of disagreement between the 2 devices, %.

Recruitment status

TERMINATED

Target enrollment

26 participants

Primary outcome timeframe

10 hours of data collected for each participant

Results posted on

2021-05-11

Participant Flow

Participants recruited from the surgical intensive care unit of Changi General Hospital, Singapore, from 2018 until 2021

Participant milestones

Participant milestones
Measure	All Participants Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac. No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=26 Participants Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac. No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	68.58 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants
Region of Enrollment Singapore	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 hours of data collected for each participant

Outcome measures

Outcome measures
Measure	All Participants n=26 Participants Patients will be treated as per department protocols and no additional intervention will be performed. Each patient will have an arterial catheter inserted as per our usual practice. All patients will have the FloTrac® connected to the arterial catheter (standard of care in CGH SICU) and the NICOM Cheetah® electrodes placed on the skin across the anterior thoracic wall. The NICOM CO monitor involves the application of non-invasive sensor strips. In this study, it will be applied to patients receiving the FloTrac (standard of care), on top of the standard care of monitoring with Flotrac. No additional intervention: Patients will be treated as per department protocols and no additional intervention will be performed
Degree of Disagreement, %	69.2 percentage of disagreement

Adverse Events

All Participants

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

Serene Yeow, Senior Executive, Clinical Trials and Research Unit

Changi General Hospital

Phone: +6581258267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place