An interventional study of NICOM (non-invasive cardiac output monitor) in Burns, sponsored by Emory University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Emory University · Not applicable, Interventional, and Health services research
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.
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.
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Exclusion Criteria:
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)
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.
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.
Total volume of fluid given
The total volume of fluid given to the subjects in the first 24 hours
Time frame: 24 hours
Rate of pressor use
Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)
Time frame: Duration of hospital stay, an expected average of 30 days
Rate of pulmonary edema
Defined as number of subjects with pulmonary edema
Time frame: Duration of hospital stay, an expected average of 30 days
Rate of acute renal failure
Defined as number of subjects with renal failure
Time frame: 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.
Time frame: 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.
Time frame: 3 months
This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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