Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
NCT Number: NCT02200055
Being able to accurately monitor patient bodily fluid levels during and after surgery is very important, as there are a number of complications that can arise if a patient's fluid levels become unbalanced, such as swelling within or pressure on various bodily organ systems. There are several different ways that physicians can monitor a patient's fluid balance during and after surgery, such as measuring the amount of urine output or the use of central venous catheters which measure the pressure in the veins entering the heart. Most of these techniques are invasive since they require tubes to be inserted into the body. A potential alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).
Bioimpedance assessments work by using small electrical currents that can accurately predict both the water surrounding the outside of cells in the body, as well as the total amount of water in the entire body. Electrical bioimpedance assessments have been used to estimate patient swelling following surgery (edema), to measure the volume of blood the heart is pumping out, as well as to calculate body fat percentages.
The goal of this study is to relate this technology to fluid shifts within the body that occur as a result of surgery, in particular, major intra-abdominal surgeries. By using bioimpedance during and after surgery, the investigators will compare the data collected with that calculated by using traditional measures of body fluid status, such as urine output and intraoperative blood loss. During the study, the bioimpedance monitors will not replace the standard bodily fluid monitors and will not interfere with their readings. Additionally, the electrical current produced by the bioimpedance monitors is too small for patients to feel and will not interfere with medical devices such as pacemakers.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Portsmouth, Virginia, 23708, United States
Being able to accurately monitor patient bodily fluid levels during and after surgery is very important, as there are a number of complications that can arise if a patient's fluid levels become unbalanced, such as swelling within or pressure on various bodily organ systems. There are several different ways that physicians can monitor a patient's fluid balance during and after surgery, such as measuring the amount of urine output or the use of central venous catheters which measure the pressure in the veins entering the heart. Most of these techniques are invasive since they require tubes to be inserted into the body. A potential alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).
Bioimpedance assessments work by using small electrical currents that can accurately predict both the water surrounding the outside of cells in the body, as well as the total amount of water in the entire body. Electrical bioimpedance assessments have been used to estimate patient swelling following surgery (edema), to measure the volume of blood the heart is pumping out, as well as to calculate body fat percentages.
The goal of this study is to relate this technology to fluid shifts within the body that occur as a result of surgery, in particular, major intra-abdominal surgeries. By using bioimpedance during and after surgery, the investigators will compare the data collected with that calculated by using traditional measures of body fluid status, such as urine output and intraoperative blood loss. During the study, the bioimpedance monitors will not replace the standard bodily fluid monitors and will not interfere with their readings. Additionally, the electrical current produced by the bioimpedance monitors is too small for patients to feel and will not interfere with medical devices such as pacemakers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.
Bioimpedance Assessment
Other names: Bioimpedance Assessment
Time frame: preoperative measurement
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Time frame: 6 hours postoperative measurement
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
Time frame: Average measurement, in ohms, taken daily for approximately 8-10 days
Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.
Time frame: preoperative measurement
Extracellular water volume was recorded for each participant before surgical procedure.
Time frame: 6 hour postoperative measurement
Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time frame: 6 hours postoperative measurement
Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time frame: Preoperative measurement
Intracellular water volume was recorded for each participant before surgical procedure.
Time frame: Sum of intakes and outputs each day while inpatient, an average of 8 days
Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period
Time frame: preoperative measurement
Overall urine output was collected preoperative
Time frame: baseline measurement
Body Mass Index was recorded for each study participant at baseline
Time frame: preoperative
A classification scale to assess the fitness of patients before surgery
The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive
Time frame: intraoperative measurement
The amount of IV fluids each patient received during the surgical procedure
United States Naval Medical Center, Portsmouth
Fed
The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation
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