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

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ClinicalTrials.gov Identifier: NCT03394768
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Chang See Seong, Changi General Hospital

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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 : August 10, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.
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




Primary Outcome Measures :
  1. Cardiac Index, L/min/m2 [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394768


Contacts
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Contact: See Seong Chang, MBBS, MMed +6591511797 chang.see.seong@singhealth.com.sg
Contact: Noelle Lim, MBBS, MMed +6568503948 noelle_lim@cgh.com.sg

Locations
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Singapore
Surgical Intensive Care Unit, Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: See S Chang    91511797    7th.element@gmail.com   
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: See Seong Chang, MBBS, MMed Changi General Hospital
  Study Documents (Full-Text)

Documents provided by Chang See Seong, Changi General Hospital:
Additional Information:

Publications:
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Responsible Party: Chang See Seong, Associate Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT03394768    
Other Study ID Numbers: 2017/2820
CHF2017.08-S ( Other Grant/Funding Number: CGH Research Grant 2017 )
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available to anyone else other than the investigators of this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms