Trial Summary
What is the purpose of this trial?The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, "static" measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid.
The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate \>= 4.0).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment NICOM for septic shock?
Research suggests that NICOM, a non-invasive cardiac output monitor, can help manage fluid levels in patients with sepsis, which is related to septic shock. It has been used to predict disease severity and assess fluid responsiveness, which are important in treating septic shock.
12345Is NICOM safe for use in humans?
NICOM, a non-invasive cardiac output monitor, has been used safely in various studies involving different patient groups, including critically ill patients, term infants, and those with pulmonary hypertension. While these studies primarily focus on its accuracy and feasibility, they do not report any significant safety concerns, suggesting it is generally safe for human use.
35678How is the NICOM treatment different from other treatments for septic shock?
NICOM is unique because it is a non-invasive method that continuously monitors cardiac output (the amount of blood the heart pumps) using bioreactance technology, which helps guide fluid management in patients with septic shock. Unlike other treatments, it does not require invasive procedures and can provide real-time data to assess fluid responsiveness.
34567Eligibility Criteria
This trial is for adult inpatients over 18 years old who have been hospitalized for at least 6 hours and are experiencing low blood pressure due to sepsis or have signs of septic shock, indicated by high lactate levels. It's not open to those who've opted out of research, patients expected to pass away within 24 hours, or those receiving end-of-life care within the first three days of hospitalization.Inclusion Criteria
I have been or will be admitted to the hospital for at least 6 hours.
I am over 18 years old.
I have sepsis, indicated by very low blood pressure or high lactate levels.
Exclusion Criteria
You were admitted to the hospital and passed away within one day.
Opted out of having their medical information used in research, as noted in the EHR
You are receiving comfort care or have been admitted to hospice within the first 72 hours of being in the hospital.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive goal-directed fluid resuscitation using the Non-Invasive Cardiac Output Monitor (NICOM) technology
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing NICOM technology which measures heart function non-invasively to guide fluid resuscitation in patients with hypotension or septic shock from sepsis. The goal is to see if this method can effectively determine when fluids should be given compared to older methods like CVP and PCWP measurements.
1Treatment groups
Experimental Treatment
Group I: Non-Invasive Cardiac Output Monitor (NICOM)Experimental Treatment1 Intervention
adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock
NICOM is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Non-Invasive Cardiac Output Monitor for:
- Monitoring cardiac output in critically ill patients
- Goal-directed fluid resuscitation in septic shock
🇪🇺 Approved in European Union as Cheetah NICOM for:
- Non-invasive hemodynamic monitoring in critical care settings
- Fluid management in sepsis and shock
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Clinical evaluation of the non-invasive cardiac output (NICO) monitor in the intensive care unit. [2022]The Non-invasive Cardiac Output (NICO) monitor (Novametrix Medical Systems Inc., Wallingford, CT, U.S.A.) utilizes a minimally-invasive partial rebreathing method to determine cardiac output by means of a differential form of the Fick equation. We evaluated the NICO monitor by comparing its output to paired measurements obtained by the standard thermodilution (TD) technique in patients who had recently undergone cardiac surgery. Forty-two paired measurements were carried out in 12 patients. The correlation between the two methods was moderate with a correlation coefficient of 0.691. Repeated measures ANOVA showed that TD measures of cardiac output were significantly higher than those obtained by the NICO monitor (P = 0.0003). Comparison of the two techniques using the method described by Bland and Altman showed decreased correlation at higher values of cardiac output. We conclude that the NICO monitor may well have a place in intensive care monitoring, provided patients are not breathing spontaneously and are able to tolerate a 4 mmHg rise in PaCO2. It is less suitable for use in patients with a high cardiac output state.
Early hemodynamic assessment using NICOM in patients at risk of developing Sepsis immediately after emergency department triage. [2021]One factor leading to the high mortality rate seen in sepsis is the subtle, dynamic nature of the disease, which can lead to delayed detection and under-resuscitation. This study investigated whether serial hemodynamic parameters obtained from a non-invasive cardiac output monitor (NICOM) predicts disease severity in patients at risk for sepsis.
Major Upper Abdominal Surgery Alters the Calibration of Bioreactance Cardiac Output Readings, the NICOM, When Comparisons Are Made Against Suprasternal and Esophageal Doppler Intraoperatively. [2022]Minimally invasive continuous cardiac output measurements are recommended for use during anesthesia to guide fluid therapy, but such measurements must trend changes reliably. The NICOM Cheetah, a BioReactance monitor, is being recommended for intraoperative use. To validate its use, Doppler methods, suprasternal USCOM and esophageal CardioQ, were used in tandem to provide reliable estimates of changing trends in cardiac output. Preliminary comparisons showed that upper abdominal surgical interventions caused shifts in the calibration of the NICOM. The purpose of this study was to confirm and measure these calibration shifts.
Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study. [2019]We investigated whether combining the caval index, assessment of the global contractility of the heart and measurement of stroke volume with Noninvasive Cardiac Output Monitoring (NICOM) can aid in fluid management in the emergency department (ED) in patients with sepsis.
Accuracy assessment of noninvasive cardiac output monitoring in the hemodynamic monitoring in critically ill patients. [2021]The consistency of cardiac output (CO) measured by noninvasive cardiac output monitoring (NICOM), pulse index continuous cardiac output (PiCCO), and ultrasound in the hemodynamic monitoring of critically ill patients was studied. Using the NICOM built-in passive leg raising (PLR) test, stroke volume index variation (∆SVI) was calculated and was used to predict volume responsiveness in patients with circulatory shock (excluding cardiogenic shock).
Feasibility of non-invasive cardiac output monitoring at birth using electrical bioreactance in term infants. [2021]Non-invasive cardiac output monitoring (NICOM) provides continuous estimation of cardiac output. This has potential for use in the delivery suite in the management of acutely depressed term infants. This study aims to measure cardiac output in term infants at delivery and in the first hours of life.
Noninvasive cardiac output measurements in patients with pulmonary hypertension. [2021]Pulmonary hypertension (PH) is characterised by a progressive decline in cardiac output (CO) and right heart failure. NICOM® (noninvasive cardiac output monitor) is a bioreactance-based technology that has been broadly validated, but its specific application in right heart failure and PH is unknown. Cardiac catheterisation was performed in 50 consecutive patients with PH. CO measurements were performed using three different methods (thermodilution, Fick and NICOM) at baseline and after vasodilator challenge. We compared the precision (coefficient of variation) and accuracy of NICOM compared to thermodilution and Fick. The mean CO (L·min(-1)) at baseline as measured by the three methods was 4.73±1.15 (NICOM), 5.69±1.74 (thermodilution) and 4.84±1.39 (Fick). CO measured by NICOM was more precise than by thermodilution (3.5±0.3% versus 9.6±6.1%, p
Non-invasive cardiac output monitoring in neonates using bioreactance: a comparison with echocardiography. [2019]Non-invasive cardiac output monitoring is a potentially useful clinical tool in the neonatal setting. Our aim was to evaluate a new method of non-invasive continuous cardiac output (CO) measurement (NICOM™) based on the principle of bioreactance in neonates.