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

The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Gastroesophageal Reflux Disease; Diverticulitis; Intestinal Cancer
• Intervention / Treatment: Device: Bodystat Quadscan 4000

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bioimpedance Assessment; 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

Device: Bodystat Quadscan 4000; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioimpedance Assessment	Bioimpedance assessment measurements were recorded for each participant before the surgical procedure	preoperative measurement
Bioimpedance Assessment	Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure	6 hours postoperative measurement
Bioimpedance Assessment	Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.	Average measurement, in ohms, taken daily for approximately 8-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Extracellular Water Volume	Extracellular water volume was recorded for each participant before surgical procedure.	preoperative measurement
Percent Intracellular Water Volume	Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.	6 hour postoperative measurement
Percent Extracellular Water Volume	Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.	6 hours postoperative measurement
Percent Intracellular Water Volume	Intracellular water volume was recorded for each participant before surgical procedure.	Preoperative measurement
Daily Fluid Balance (Intakes and Outputs)	Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period	Sum of intakes and outputs each day while inpatient, an average of 8 days
Urine Output	Overall urine output was collected preoperative	preoperative measurement
Study Characteristics of Participants: Body Mass Index	Body Mass Index was recorded for each study participant at baseline	baseline measurement
American Society of Anaesthesiologists Physical Status Classification Scale	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	preoperative
Amount of Intraoperative Fluids	The amount of IV fluids each patient received during the surgical procedure	intraoperative measurement

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, Portsmouth
• Investigators: Principal Investigator: Christopher Oxner, MD, United States Naval Medical Center, Portsmouth

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Fluid Resuscitation; Electrical Bioimpedance; Major Intra-abdominal Surgical Procedures; Total Body Volume
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Diverticular Diseases; Gastroesophageal Reflux; Diverticulitis; Intestinal Neoplasms
• Other Study ID Numbers: CIP# 12-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No