CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Bodystat Quadscan 4000device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02200055
NCT02200055N/ACompleted

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

United States Naval Medical Center, Portsmouth·interventional·Posted Jul 25, 2014·Updated Aug 28, 2018

In Brief

A clinical study evaluating Bodystat Quadscan 4000 for Intestinal Cancer and 3 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2014
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.9 years ago

Interventions

Bodystat Quadscan 4000device

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