Diverticulitis, Gastroesophageal Reflux Disease, Intestinal Cancer, Pancreatic Cancer
Conditions
Keywords
Electrical Bioimpedance, Major Intra-abdominal Surgical Procedures, Total Body Volume, Fluid Resuscitation
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.
Detailed 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.
Interventions
DEVICEBodystat 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
Sponsors
United States Naval Medical Center, Portsmouth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioimpedance Assessment | preoperative measurement | Bioimpedance assessment measurements were recorded for each participant before the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Extracellular Water Volume | preoperative measurement | Extracellular water volume was recorded for each participant before surgical procedure. |
| Percent Intracellular Water Volume | 6 hour postoperative measurement | Intracellular water volume was recorded for each participant 6 hours following the surgical procedure. |
| Daily Fluid Balance (Intakes and Outputs) | 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 |
| Urine Output | preoperative measurement | Overall urine output was collected preoperative |
| American Society of Anaesthesiologists Physical Status Classification Scale | 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 |
| Amount of Intraoperative Fluids | intraoperative measurement | The amount of IV fluids each patient received during the surgical procedure |
| Study Characteristics of Participants: Body Mass Index | baseline measurement | Body Mass Index was recorded for each study participant at baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.
Bioimpedance Assessment
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 | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Bioimpedance Assessment |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 13.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 3 / 90 |
| serious Total, serious adverse events | 3 / 90 |
Outcome results
Primary
Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
Time frame: 6 hours postoperative measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Bioimpedance Assessment | 0.57 ohms | Standard Deviation 0.07 |
Primary
Bioimpedance Assessment
Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.
Time frame: Average measurement, in ohms, taken daily for approximately 8-10 days
Population: This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Bioimpedance Assessment | 0.59 ohms | Standard Deviation 0.24 |
Primary
Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Time frame: preoperative measurement
Population: This is the population of participants with bioimpedance measurements taken preoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Bioimpedance Assessment | 0.53 ohms | Standard Deviation 0.06 |
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
Time frame: preoperative
Population: An ASA classification was recorded for each participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | American Society of Anaesthesiologists Physical Status Classification Scale | 2.2 units on a scale | Standard Deviation 0.56 |
Secondary
Amount of Intraoperative Fluids
The amount of IV fluids each patient received during the surgical procedure
Time frame: intraoperative measurement
Population: The population of participants with recorded data on the amount of IV fluids used during surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Amount of Intraoperative Fluids | 2472.6 mL | Standard Deviation 1147 |
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
Time frame: Sum of intakes and outputs each day while inpatient, an average of 8 days
Population: This was the final amount of participants who met all study eligibility requirements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Daily Fluid Balance (Intakes and Outputs) | 1163.1 mL | Standard Deviation 1061.8 |
Secondary
Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant before surgical procedure.
Time frame: preoperative measurement
Population: This is the final number of participants who met all study eligibility requirements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Percent Extracellular Water Volume | 0.89 percent of total water volume | Standard Deviation 3.68 |
Secondary
Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time frame: 6 hours postoperative measurement
Population: This population contains data with extracellular water volume measurements taken post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Percent Extracellular Water Volume | 0.32 percent of total water volume | Standard Deviation 0.34 |
Secondary
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant before surgical procedure.
Time frame: Preoperative measurement
Population: This population includes data on participants with recorded intracellular water volume measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Percent Intracellular Water Volume | 0.30 percent of total water volume | Standard Deviation 0.04 |
p-value: <0.01Chi-squared
Secondary
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Time frame: 6 hour postoperative measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Percent Intracellular Water Volume | 0.82 percent of total water volume | Standard Deviation 1.54 |
Secondary
Study Characteristics of Participants: Body Mass Index
Body Mass Index was recorded for each study participant at baseline
Time frame: baseline measurement
Population: Baseline BMI was recorded for each participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Study Characteristics of Participants: Body Mass Index | 27 kg/m^2 | Standard Deviation 5 |
Secondary
Urine Output
Overall urine output was collected preoperative
Time frame: preoperative measurement
Population: This population of participants recorded their urine output under preoperative conditions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioimpedance Assessment | Urine Output | 406.7 mL | Standard Deviation 430 |