Cardiac Output Monitoring in Burn Patients

Study Overview
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Brief Summary
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The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.

Detailed Description
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Appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. Currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. The NICOM has been used in the resuscitation of patients with sepsis. The NICOM will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

Official Title
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Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries

Conditions
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Burns

Intervention / Treatment
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* Device: NICOM (non-invasive cardiac output monitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Burn greater than 20% TBSA (total body surface area) Exclusion Criteria: 1) Burn less than 20% TBSA (total body surface area)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NICOM<br>Subjects with burns greater than 20% total body surface area (TBSA) will have a NICOM placed on them after the first 24 hours of admission if subject has an episode of hypotension (mean arterial pressure < 65 or a systolic blood pressure < 90mmHg). The NICOM will generate a number that reflects stroke volume of the heart. If the number is greater than 10 percent, subject will be given a bolus of crystalloid fluids. If the number is less than 10 percent, subject will start a medication to raise the blood pressure. Physicians may also use traditional endpoints of resuscitation include base deficit values and urine output goals of 0.5cc/kg/hr as indications of adequate intravenous fluid resuscitation. | Device: NICOM (non-invasive cardiac output monitor)<br>* The non-invasive cardiac output monitor (NICOM) will be used to tailor fluid management to optimize resuscitation if the patient has an episode of hypotension (defined as systolic blood pressure <100 or mean arterial pressure <65). NICOM consists of two electrodes placed on the patient's chest and back and uses bioreactance technology to transduce signals to compute hemodynamic parameters on an associated monitor. The electrodes will remain on the patient for twenty minutes. Once the electrodes are in place the patient's leg will be raised to 45 degrees and the monitor to which the electrodes are attached will generate a number that reflects stroke volume of the heart. The electrodes will be removed once this number is determined.<br>|
| No Intervention: Control<br>This is a retrospective comparison control group of patients with burns greater than 20% total body surface area (TBSA) admitted to the hospital from 7/1/2014-12/31/2014. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of fluid given | The total volume of fluid given to the subjects in the first 24 hours | 24 hours | 
| Rate of pressor use | Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents) | Duration of hospital stay, an expected average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pulmonary edema | Defined as number of subjects with pulmonary edema | Duration of hospital stay, an expected average of 30 days | 
| Rate of acute renal failure | Defined as number of subjects with renal failure | Duration of hospital stay, an expected average of 30 days | 
| Length of stay in intensive care unit (ICU) | Defined as the number of days from date of admission to date of first ICU discharge. | 3 months | 
| Length of hospital stay | Defined as the number of days from date of admission to date of first hospital discharge, regardless of if subject was discharged to home or other location. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac output, Low blood pressure, Total Body Surface Area (TBSA)