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

NCT03394768 | Terminated Results

• 2 other identifiers: 2017/2820CHF2017.08-S
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output, Low

Outcome Measures

Primary Outcomes (1)

• Degree of Disagreement, %

  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

Study Arms (2)

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

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

Interventions

No additional intervention OTHER

Patients will be treated as per department protocols and no additional intervention will be performed

FloTrac®; NICOM Cheetah®

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who are not on mechanical ventilation.
• Patients who are not in sinus rhythm.
• Patients with allergy to adhesive tapes

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Surgical Intensive Care Unit, Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (4)

• 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.

  PMID: 17458538 BACKGROUND

• 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.

  PMID: 18340540 BACKGROUND

• 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.

  PMID: 19454009 BACKGROUND

• 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.

  PMID: 25276302 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Serene Yeow, Senior Executive, Clinical Trials and Research Unit
• Organization: Changi General Hospital

serene_yeow@cgh.com.sg

+6581258267

Study Officials

• See Seong Chang, MBBS, MMed

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

• Louis Ng, MBBS, ANZCA

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: August 10, 2018
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: May 11, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)