Clinical trial NCT02200055: Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need
Official title: The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Cancer
Diverticulitis
Pancreatic Cancer
Gastroesophageal Reflux Disease
Keywords: Electrical Bioimpedance
Major Intra-abdominal Surgical Procedures
Total Body Volume
Fluid Resuscitation
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2014-07-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bioimpedance Assessment
timeFrame: preoperative measurement
measure: Bioimpedance Assessment
timeFrame: 6 hours postoperative measurement
measure: Bioimpedance Assessment
timeFrame: Average measurement, in ohms, taken daily for approximately 8-10 days
Secondary outcomes:
measure: Percent Extracellular Water Volume
timeFrame: preoperative measurement
measure: Percent Intracellular Water Volume
timeFrame: 6 hour postoperative measurement
measure: Percent Extracellular Water Volume
timeFrame: 6 hours postoperative measurement
measure: Percent Intracellular Water Volume
timeFrame: Preoperative measurement
measure: Daily Fluid Balance (Intakes and Outputs)
timeFrame: Sum of intakes and outputs each day while inpatient, an average of 8 days
measure: Urine Output
timeFrame: preoperative measurement
measure: Study Characteristics of Participants: Body Mass Index
timeFrame: baseline measurement
measure: American Society of Anaesthesiologists Physical Status Classification Scale
timeFrame: preoperative
measure: Amount of Intraoperative Fluids
timeFrame: intraoperative measurement
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, Portsmouth
name: Christopher Oxner, MD
role: PRINCIPAL_INVESTIGATOR
References: