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NCT Number: NCT02200055

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Bioimpedance Assessment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, Portsmouth

Fed

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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