An observational study in Cardiac Output, Low, sponsored by Changi General Hospital. Terminated at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by Changi General Hospital · Observational
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.
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.
99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.
This study's enrollment of 26 is below the median of 66 across 48 observational studies indexed under Cardiac Output, Low.
Browse Cardiac Output, Low studies →Changi General Hospital is the lead sponsor of 101 studies on the registry; 18 are open to participants now.
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Patients admitted to the surgical intensive care unit (SICU) who are deemed to require cardiac output monitoring by the treating intensivist
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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, %.
Time frame: 10 hours of data collected for each participant
Participants recruited from the surgical intensive care unit of Changi General Hospital, Singapore, from 2018 until 2021
| Milestone | All Participants |
|---|---|
| Started | 26 |
| Completed | 26 |
| Not completed | 0 |
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, %.
| percentage of disagreement | All Participants |
|---|---|
| Degree of Disagreement, % | 69.2 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 13 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 68.58 ± 12.4 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 11 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 26 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| Singapore | 26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD will not be available to anyone else other than the investigators of this study
Ran from Aug 2018 to primary completion in Jan 2021, 28 months.
Results were first posted in Mar 2021, 1 month after primary completion.
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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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