Cardiac Output, LowNCT03394768
Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.
An observational study of Cardiac Output, Low, run by Changi General Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- No additional intervention
- How many people
- 26 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Aug 2018to 5 Jan 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist
Who may be able to join
- 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
Who cannot join
- Patients who are not on mechanical ventilation.
- Patients who are not in sinus rhythm.
- Patients with allergy to adhesive tapes
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Surgical Intensive Care Unit, Changi General Hospital
Singapore, 529889
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Output, Low
- Being tested
- No additional intervention
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No additional interventionOther
Patients will be treated as per department protocols and no additional intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: No additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, %.
Measured: 10 hours of data collected for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start10 Aug 2018
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Why it stopped: Interim analysis shown futility to continue due to lack of benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang See Seong, Changi General Hospital
- Investigators
- See Seong Chang, MBBS, MMed, Principal investigator, Changi General HospitalLouis Ng, MBBS, ANZCA, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394768
- Sponsor's protocol ID
- 2017/2820
- Other IDs
- CHF2017.08-S
- Status last verified
- May 2021
- First submitted
- 3 Jan 2018
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to anyone else other than the investigators of this study
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.
PubMed 17458538Raval 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.
PubMed 18340540Marque 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.
PubMed 19454009Mehta 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.
PubMed 25276302
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Comparing NICOM-Cheetah Versus Flotrac-Vigileo for Cardiac Output Monitoring in the Surgical Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03394768
- Acronym / sponsor ID
- 2017/2820
- Conditions
- Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis shown futility to continue due to lack of benefit.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICOM Cheetah® | – | Other: No additional interventionPatients 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. |
| FloTrac® | – | Other: No additional interventionSame 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who are not on mechanical ventilation.
- Patients who are not in sinus rhythm.
- Patients with allergy to adhesive tapes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No additional interventionPatients will be treated as per department protocols and no additional intervention will be performed | Other | FloTrac®, NICOM Cheetah® |
Primary outcome
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, %.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17458538Squara 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.
- Background: PubMed 18340540Raval 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.
- Background: PubMed 19454009Marque 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.
- Background: PubMed 25276302Mehta 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.
- Individual participant dataSharing planned: No. IPD will not be available to anyone else other than the investigators of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
See Seong Chang, MBBS, MMed principal investigator
Changi General Hospital
Louis Ng, MBBS, ANZCA principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Disagreement, % (time frame: 10 hours of data collected for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394768, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.