Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioimpedance Assessment | Experimental | 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, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Oxner, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
The number of participants meeting study eligibility requirements
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bioimpedance Assessment | Bioimpedance assessment measurements were recorded for each participant before the surgical procedure | This is the population of participants with bioimpedance measurements taken preoperative | Posted | Mean | Standard Deviation | ohms | preoperative measurement |
|
|
| |||||||||||||||||||||||||
| Primary | Bioimpedance Assessment | Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure | Posted | Mean | Standard Deviation | ohms | 6 hours postoperative measurement |
|
|
| ||||||||||||||||||||||||||
| Primary | Bioimpedance Assessment | Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded. | This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded | Posted | Mean | Standard Deviation | ohms | 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. | This is the final number of participants who met all study eligibility requirements | Posted | Mean | Standard Deviation | percent of total water volume | preoperative measurement |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Intracellular Water Volume | Intracellular water volume was recorded for each participant 6 hours following the surgical procedure. | Posted | Mean | Standard Deviation | percent of total water volume | 6 hour postoperative measurement |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Extracellular Water Volume | Extracellular water volume was recorded for each participant 6 hours following the surgical procedure. | This population contains data with extracellular water volume measurements taken post-operative | Posted | Mean | Standard Deviation | percent of total water volume | 6 hours postoperative measurement |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Intracellular Water Volume | Intracellular water volume was recorded for each participant before surgical procedure. | This population includes data on participants with recorded intracellular water volume measurements | Posted | Mean | Standard Deviation | percent of total water volume | 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 | This was the final amount of participants who met all study eligibility requirements | Posted | Mean | Standard Deviation | mL | Sum of intakes and outputs each day while inpatient, an average of 8 days |
|
| ||||||||||||||||||||||||||
| Secondary | Urine Output | Overall urine output was collected preoperative | This population of participants recorded their urine output under preoperative conditions | Posted | Mean | Standard Deviation | mL | preoperative measurement |
|
|
| |||||||||||||||||||||||||
| Secondary | Study Characteristics of Participants: Body Mass Index | Body Mass Index was recorded for each study participant at baseline | Baseline BMI was recorded for each participant | Posted | Mean | Standard Deviation | kg/m^2 | 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 | An ASA classification was recorded for each participant | Posted | Mean | Standard Deviation | units on a scale | preoperative |
|
| ||||||||||||||||||||||||||
| Secondary | Amount of Intraoperative Fluids | The amount of IV fluids each patient received during the surgical procedure | The population of participants with recorded data on the amount of IV fluids used during surgery | Posted | Mean | Standard Deviation | mL | intraoperative measurement |
|
|
Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014.
At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 90 | 3 | 90 | 3 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| perineal wound infection | Infections and infestations | Other | Systematic Assessment | Post-op infection leading to hospital admission |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment | bronchospasm during surgery |
|
| upper gastrointestinal bleed | Gastrointestinal disorders | Other | Non-systematic Assessment | resulted in re-admission |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Vascular disorders | Other | Systematic Assessment |
| |
| hemoperitoneum | Blood and lymphatic system disorders | Other | Systematic Assessment |
| |
| pancreatic leak | Gastrointestinal disorders | Other | Systematic Assessment |
|
Due to the number of participants who did not meet study eligibility requirements, we were only able to use 45 of 86 participants' data. Therefore, due such a small sample size, results from this study may lack generalizability.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Oxner | General Surgery, Naval Medical Center Porstmouth | 757-953-2495 | christopher.r.oxner.mil@mail.mil |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004238 | Diverticulitis |
| D010190 | Pancreatic Neoplasms |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|
| Title | Denominators | Categories |
|---|
|