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2012-05
2015-07
2015-07
86
NCT02200055
United States Naval Medical Center, Portsmouth
United States Naval Medical Center, Portsmouth
INTERVENTIONAL
Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-06-18 | 2018-03-08 | 2018-08-23 |
2014-07-24 | 2018-08-23 | 2018-08-28 |
2014-07-25 | 2018-08-28 | 2018-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 | DEVICE: Bodystat Quadscan 4000
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
