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

NCT02200055 | Completed Results FDA Device

• 1 other identifier: CIP# 12-0050
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Cancer; Diverticulitis; Pancreatic Cancer; Gastroesophageal Reflux Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Percent Extracellular Water Volume

  preoperative measurement

• Percent Intracellular Water Volume

  6 hour postoperative measurement

• Percent Extracellular Water Volume

  6 hours postoperative measurement

• Percent Intracellular Water Volume

  Preoperative measurement

• Daily Fluid Balance (Intakes and Outputs)

  Sum of intakes and outputs each day while inpatient, an average of 8 days

Study Arms (1)

Bioimpedance Assessment

EXPERIMENTAL

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

Interventions

Bodystat Quadscan 4000 DEVICE

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

Also known as: Bioimpedance Assessment

Bioimpedance Assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Intestinal Neoplasms; Diverticulitis; Pancreatic Neoplasms; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Diverticular Diseases; Gastroenteritis; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Limitations and Caveats

Due to the number of participants who did not meet study eligibility requirements, we were only able to use 45 of 86 participants' data. Therefore, due such a small sample size, results from this study may lack generalizability.

Results Point of Contact

• Title: Dr. Christopher Oxner
• Organization: General Surgery, Naval Medical Center Porstmouth

christopher.r.oxner.mil@mail.mil

757-953-2495

Study Officials

• Christopher Oxner, MD

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: July 25, 2014
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)