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

Primary Purpose

Intestinal Cancer, Diverticulitis, Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodystat Quadscan 4000
Sponsored by
United States Naval Medical Center, Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intestinal Cancer focused on measuring Electrical Bioimpedance, Major Intra-abdominal Surgical Procedures, Total Body Volume, Fluid Resuscitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naval Medical Center Portsmouth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bioimpedance Assessment

Arm Description

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

Outcomes

Primary Outcome Measures

Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
Bioimpedance Assessment
Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.

Secondary Outcome Measures

Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant before surgical procedure.
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant before surgical procedure.
Daily Fluid Balance (Intakes and Outputs)
Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period
Urine Output
Overall urine output was collected preoperative
Study Characteristics of Participants: Body Mass Index
Body Mass Index was recorded for each study participant at baseline
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
Amount of Intraoperative Fluids
The amount of IV fluids each patient received during the surgical procedure

Full Information

First Posted
June 18, 2014
Last Updated
August 23, 2018
Sponsor
United States Naval Medical Center, Portsmouth
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1. Study Identification

Unique Protocol Identification Number
NCT02200055
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, Portsmouth

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Cancer, Diverticulitis, Pancreatic Cancer, Gastroesophageal Reflux Disease
Keywords
Electrical Bioimpedance, Major Intra-abdominal Surgical Procedures, Total Body Volume, Fluid Resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioimpedance Assessment
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bodystat Quadscan 4000
Other Intervention Name(s)
Bioimpedance Assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
Bioimpedance Assessment
Description
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Time Frame
preoperative measurement
Title
Bioimpedance Assessment
Description
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
Time Frame
6 hours postoperative measurement
Title
Bioimpedance Assessment
Description
Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.
Time Frame
Average measurement, in ohms, taken daily for approximately 8-10 days
Secondary Outcome Measure Information:
Title
Percent Extracellular Water Volume
Description
Extracellular water volume was recorded for each participant before surgical procedure.
Time Frame
preoperative measurement
Title
Percent Intracellular Water Volume
Description
Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time Frame
6 hour postoperative measurement
Title
Percent Extracellular Water Volume
Description
Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time Frame
6 hours postoperative measurement
Title
Percent Intracellular Water Volume
Description
Intracellular water volume was recorded for each participant before surgical procedure.
Time Frame
Preoperative measurement
Title
Daily Fluid Balance (Intakes and Outputs)
Description
Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period
Time Frame
Sum of intakes and outputs each day while inpatient, an average of 8 days
Title
Urine Output
Description
Overall urine output was collected preoperative
Time Frame
preoperative measurement
Title
Study Characteristics of Participants: Body Mass Index
Description
Body Mass Index was recorded for each study participant at baseline
Time Frame
baseline measurement
Title
American Society of Anaesthesiologists Physical Status Classification Scale
Description
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
preoperative
Title
Amount of Intraoperative Fluids
Description
The amount of IV fluids each patient received during the surgical procedure
Time Frame
intraoperative measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Oxner, MD
Organizational Affiliation
United States Naval Medical Center, Portsmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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