Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.
May 10, 2021 updated by: Chang See Seong, Changi General Hospital
An Observational Study Comparing NICOM-Cheetah Versus Flotrac-Vigileo for Cardiac Output Monitoring in the Surgical Intensive Care Unit.
Cardiac output (CO) monitoring is an important tool in critically ill patients with haemodynamic instability.
Traditionally, this has been accomplished using the pulmonary artery catheter (PAC).
However, its use has been associated with various complications such as pneumothorax, arrhythmia, infection, pulmonary valve injury and embolism.
This has led to the development of various minimally invasive cardiac output monitoring devices such as the oesophageal Doppler, PiCCO®, NiCCO® and FloTrac®.
These devices however have their inherent limitations and though minimally invasive, are still not without risks to the patient.
More recently a completely non-invasive CO monitoring device, NICOM Cheetah® has been introduced.
Its use is based on thoracic bioreactance and it involves placement of 4 electrodes on either side of the thorax and it analyses changes in the phase of electrical voltage signal to the current applied across the thorax.
Initial validation studies on the NICOM Cheetah® device revealed promising results.
This study intends to compare cardiac output monitoring capabilities of the NICOM Cheetah® device using the FloTrac® CO monitor as a reference.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This will be a single centre prospective observational study.
50 consecutive patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist will be studied.
Data collection is planned to be carried out over 2 consecutive years.
Inclusion criteria are: 1) Patients who are deemed to require cardiac output monitoring.
2) Patients 21 years old and above.
3) American Society of Anesthesiologist (ASA) physical status 1 to 4. Exclusion criteria are: 1) Patients who are not on mechanical ventilation.
2) Patients who are not in sinus rhythm.
3) Patients with allergy to adhesive tapes.
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 FloTrac CO monitor is the current standard of care for cardiac output monitoring in the SICU of CGH.
All patients deemed to require cardiac output monitoring will receive the FloTrac (as per departmental practice).
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.
For each patient, standard demographic and SICU data (age, gender, comorbidities, ASA score, admission diagnosis, type of surgery, cause of haemodynamic instability, mean arterial pressure (MAP) and central venous pressure (CVP) at the time of instituting cardiac output (CO) monitoring, use of inotropic support, presence of renal replacement therapy, presence of mechanical ventilation and APACHE II score) will be collected.
Cardiac Index (CI) values simultaneously recorded by the NICOM Cheetah® and FloTrac® on a 15-minutely basis for the first 10-hour period will also be collected.
These data will be automatically recorded by the FloTrac® Vigilance monitor and the Cheetah NICOM monitor and transcribed to a data entering/analysis software by the principal and co-principal investigators for data analysis.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 529889
- Surgical Intensive Care Unit, Changi General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist
Description
Inclusion Criteria:
- Patients who are deemed to require cardiac output monitoring.
- Patients 21 years old and above
- American Society of Anesthesiologist (ASA) physical status 1 to 4
Exclusion Criteria:
- Patients who are not on mechanical ventilation.
- Patients who are not in sinus rhythm.
- Patients with allergy to adhesive tapes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
NICOM Cheetah®
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.
|
Patients will be treated as per department protocols and no additional intervention will be performed
|
|
FloTrac®
Same patient population as the NICOM Cheetah® group as described above as 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 FloTrac CO monitor is the current standard of care for cardiac output monitoring in the SICU of CGH.
All patients deemed to require cardiac output monitoring will receive the FloTrac (as per departmental practice).
|
Patients will be treated as per department protocols and no additional intervention will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Disagreement, %
Time Frame: 10 hours of data collected for each participant
|
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, %.
|
10 hours of data collected for each participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: See Seong Chang, MBBS, MMed, Changi General Hospital
- Principal Investigator: Louis Ng, MBBS, ANZCA, Changi General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26.
- Raval NY, Squara P, Cleman M, Yalamanchili K, Winklmaier M, Burkhoff D. Multicenter evaluation of noninvasive cardiac output measurement by bioreactance technique. J Clin Monit Comput. 2008 Apr;22(2):113-9. doi: 10.1007/s10877-008-9112-5. Epub 2008 Mar 14.
- Marque S, Cariou A, Chiche JD, Squara P. Comparison between Flotrac-Vigileo and Bioreactance, a totally noninvasive method for cardiac output monitoring. Crit Care. 2009;13(3):R73. doi: 10.1186/cc7884. Epub 2009 May 19.
- Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2018
Primary Completion (Actual)
January 5, 2021
Study Completion (Actual)
January 5, 2021
Study Registration Dates
First Submitted
January 3, 2018
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/2820
- CHF2017.08-S (Other Grant/Funding Number: CGH Research Grant 2017)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IPD will not be available to anyone else other than the investigators of this study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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