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

• Sponsor: Changi General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03394768
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Actual Duration (Months): 28.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output, Low	Other: No additional intervention

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 26 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Study Comparing NICOM-Cheetah Versus Flotrac-Vigileo for Cardiac Output Monitoring in the Surgical Intensive Care Unit.
• Actual Study Start Date: Aug 10, 2018
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

Arm	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.	Other: No additional intervention; 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).	Other: No additional intervention; Patients will be treated as per department protocols and no additional intervention will be performed

Outcome Measures

Primary Outcome Measures

1. Degree of Disagreement, % [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, %.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical Intensive Care Unit, Changi General Hospital	Singapore		Singapore	529889

Sponsors and Collaborators

• Changi General Hospital

Investigators

• Principal Investigator: See Seong Chang, MBBS, MMed, Changi General Hospital
• Principal Investigator: Louis Ng, MBBS, ANZCA, Changi General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2018

More Information

Publications

• Marqué 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. Review.
• 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.
• 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.

• Responsible Party: Chang See Seong, Consultant, Changi General Hospital
• ClinicalTrials.gov Identifier: NCT03394768
• Other Study ID Numbers: 2017/2820; CHF2017.08-S
• First Posted: Jan 9, 2018
• Last Update Posted: May 11, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiac Output, Low

Study Results

Participant Flow

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

Arm/Group Title	All Participants
Arm/Group Description	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
Period Title: Overall Study
STARTED	26
COMPLETED	26
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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 Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 50%
>=65 years	13 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.58 (12.4)
Sex: Female, Male (Count of Participants)
Female	11 42.3%
Male	15 57.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	26 100%
Region of Enrollment (participants) [Number]
Singapore	26 100%

Outcome Measures

1. Primary Outcome

Title	Degree of Disagreement, %
Description	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, %.
Time Frame	10 hours of data collected for each participant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	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
Measure Participants	26
Number [percentage of disagreement]	69.2

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed.
Arm/Group Title	All Participants
Arm/Group Description	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
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.