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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200055
• Other study ID #: CIP# 12-0050
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2018
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Intestinal Cancer
• Intestinal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioimpedance Assessment	Bioimpedance assessment measurements were recorded for each participant before the surgical procedure	preoperative measurement
Primary	Bioimpedance Assessment	Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure	6 hours postoperative measurement
Primary	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	Percent Extracellular Water Volume	Extracellular water volume was recorded for each participant before surgical procedure.	preoperative measurement
Secondary	Percent Intracellular Water Volume	Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.	6 hour postoperative measurement
Secondary	Percent Extracellular Water Volume	Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.	6 hours postoperative measurement
Secondary	Percent Intracellular Water Volume	Intracellular water volume was recorded for each participant before surgical procedure.	Preoperative measurement
Secondary	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
Secondary	Urine Output	Overall urine output was collected preoperative	preoperative measurement
Secondary	Study Characteristics of Participants: Body Mass Index	Body Mass Index was recorded for each study participant at baseline	baseline measurement
Secondary	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
Secondary	Amount of Intraoperative Fluids	The amount of IV fluids each patient received during the surgical procedure	intraoperative measurement