Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need

Not Applicable

Completed

Conditions: Intestinal Cancer
Pancreatic Cancer
Gastroesophageal Reflux Disease
Diverticulitis

Interventions: Device: Bodystat Quadscan 4000

Registration Number: NCT02200055

Lead Sponsor: United States Naval Medical Center, Portsmouth

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

Patients having major intra-abdominal procedures under general anesthesia requiring hospitalization postoperatively during the initial recovery from surgery.

Exclusion Criteria

Patients not having intra-abdominal procedures (ie. Thyroidectomy, open or laparoscopic inguinal hernia repair, excision of skin lesions, breast procedures)
Patients having outpatient surgery
Patients having laparoscopic cholecystectomies, laparoscopic or open appendectomies
Patients having bariatric surgery (because the bioimpedance assessment technology has proven to be unreliable in obese populations)
Morbidly obese patients (BMI >40)
Unable to provide informed consent
Pregnant women

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bioimpedance Assessment	Bodystat Quadscan 4000	The only group will be those patients having major intra-abdominal surgical procedures. Each patient involved in the study will be evaluated with a bioimpedance monitor ('Bodystat Quadscan 4000') to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment

Primary Outcome Measures

Name	Time	Method
Bioimpedance Assessment	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.

Secondary Outcome Measures

Name	Time	Method
Daily Fluid Balance (Intakes and Outputs)	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
Urine Output	preoperative measurement	Overall urine output was collected preoperative
American Society of Anaesthesiologists Physical Status Classification Scale	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
Study Characteristics of Participants: Body Mass Index	baseline measurement	Body Mass Index was recorded for each study participant at baseline
Amount of Intraoperative Fluids	intraoperative measurement	The amount of IV fluids each patient received during the surgical procedure
Percent Extracellular Water Volume	6 hours postoperative measurement	Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Percent Intracellular Water Volume	Preoperative measurement	Intracellular water volume was recorded for each participant before surgical procedure.