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

• ClinicalTrials.gov Identifier: NCT02200055
• Recruitment Status: Completed
• First Posted: July 25, 2014
• Results First Posted: August 28, 2018
• Last Update Posted: August 28, 2018
• Sponsor: United States Naval Medical Center, Portsmouth
• Information provided by (Responsible Party): Christian McEvoy, United States Naval Medical Center, Portsmouth

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.

Condition or disease	Intervention/treatment	Phase
Intestinal Cancer; Diverticulitis; Pancreatic Cancer; Gastroesophageal Reflux Disease	Device: Bodystat Quadscan 4000	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation
• Study Start Date: May 2012
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

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 Name: Bioimpedance Assessment

Outcome Measures

Primary Outcome Measures :

1. Bioimpedance Assessment [ Time Frame: preoperative measurement ]
   Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
2. Bioimpedance Assessment [ Time Frame: 6 hours postoperative measurement ]
   Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
3. Bioimpedance Assessment [ 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.

Secondary Outcome Measures :

1. Percent Extracellular Water Volume [ Time Frame: preoperative measurement ]
   Extracellular water volume was recorded for each participant before surgical procedure.
2. Percent Intracellular Water Volume [ Time Frame: 6 hour postoperative measurement ]
   Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
3. Percent Extracellular Water Volume [ Time Frame: 6 hours postoperative measurement ]
   Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
4. Percent Intracellular Water Volume [ Time Frame: Preoperative measurement ]
   Intracellular water volume was recorded for each participant before surgical procedure.
5. Daily Fluid Balance (Intakes and Outputs) [ 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
6. Urine Output [ Time Frame: preoperative measurement ]
   Overall urine output was collected preoperative
7. Study Characteristics of Participants: Body Mass Index [ Time Frame: baseline measurement ]
   Body Mass Index was recorded for each study participant at baseline
8. American Society of Anaesthesiologists Physical Status Classification Scale [ 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

9. Amount of Intraoperative Fluids [ Time Frame: intraoperative measurement ]
   The amount of IV fluids each patient received during the surgical procedure

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Virginia

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States, 23708

Sponsors and Collaborators

United States Naval Medical Center, Portsmouth

Investigators

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

More Information

• Responsible Party: Christian McEvoy, General Surgery Resident, United States Naval Medical Center, Portsmouth
• ClinicalTrials.gov Identifier: NCT02200055
• Other Study ID Numbers: CIP# 12-0050
• First Posted: July 25, 2014
• Results First Posted: August 28, 2018
• Last Update Posted: August 28, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Christian McEvoy, United States Naval Medical Center, Portsmouth:

Electrical Bioimpedance; Major Intra-abdominal Surgical Procedures; Total Body Volume; Fluid Resuscitation

Additional relevant MeSH terms:

Intestinal Neoplasms; Gastroesophageal Reflux; Diverticulitis; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Diverticular Diseases; Gastroenteritis; Gastrointestinal Neoplasms; Intestinal Diseases