Intestinal CancerNCT02200055
Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need
A study testing Bodystat Quadscan 4000 in people with Intestinal Cancer and Diverticulitis, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Cancer, Diverticulitis, Pancreatic Cancer
- What is being tested?
- Bodystat Quadscan 4000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having major intra-abdominal procedures under general anesthesia requiring hospitalization postoperatively during the initial recovery from surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation
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.
Read the 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.
- Being tested
- Bodystat Quadscan 4000
- Keywords
- Electrical Bioimpedance, Major Intra-abdominal Surgical Procedures, Total Body Volume, Fluid Resuscitation
- Medical subject headings
- Intestinal Neoplasms, Diverticulitis, Pancreatic Neoplasms, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodystat Quadscan 4000Device
Also called Bioimpedance Assessment
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Bodystat Quadscan 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Measured: preoperative measurement
Bioimpedance Assessment
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
Measured: 6 hours postoperative measurement
Bioimpedance Assessment
Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.
Measured: Average measurement, in ohms, taken daily for approximately 8-10 days
Secondary outcomes (9)
Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant before surgical procedure.
Measured: preoperative measurement
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Measured: 6 hour postoperative measurement
Percent Extracellular Water Volume
Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.
Measured: 6 hours postoperative measurement
Percent Intracellular Water Volume
Intracellular water volume was recorded for each participant before surgical procedure.
Measured: 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
Measured: Sum of intakes and outputs each day while inpatient, an average of 8 days
Urine Output
Overall urine output was collected preoperative
Measured: preoperative measurement
Study Characteristics of Participants: Body Mass Index
Body Mass Index was recorded for each study participant at baseline
Measured: 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
Measured: preoperative
Amount of Intraoperative Fluids
The amount of IV fluids each patient received during the surgical procedure
Measured: intraoperative measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christian McEvoy, United States Naval Medical Center, Portsmouth
- Investigators
- Christopher Oxner, MD, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200055
- Sponsor's protocol ID
- CIP# 12-0050
- Status last verified
- Aug 2018
- First submitted
- 18 Jun 2014
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Multifrequency Bioimpedance Assessments as an Estimate of Perioperative Total Body Volume and Postoperative Fluid Resuscitation
- ClinicalTrials.gov ID
- NCT02200055
- Acronym / sponsor ID
- CIP# 12-0050
- Keywords
- Electrical Bioimpedance, Major Intra-abdominal Surgical Procedures, Total Body Volume, Fluid Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioimpedance Assessment | Experimental | Device: Bodystat Quadscan 4000The 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having major intra-abdominal procedures under general anesthesia requiring hospitalization postoperatively during the initial recovery from surgery.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodystat Quadscan 4000Also: Bioimpedance AssessmentEach 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 | Device | Bioimpedance Assessment |
Primary outcome
Bioimpedance Assessment
Time frame: preoperative measurement
Bioimpedance assessment measurements were recorded for each participant before the surgical procedure
Bioimpedance Assessment
Time frame: 6 hours postoperative measurement
Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure
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.
9 secondary outcomes
Percent Extracellular Water Volume
Time frame: preoperative measurement
Percent Intracellular Water Volume
Time frame: 6 hour postoperative measurement
Percent Extracellular Water Volume
Time frame: 6 hours postoperative measurement
Percent Intracellular Water Volume
Time frame: Preoperative measurement
Daily Fluid Balance (Intakes and Outputs)
Time frame: Sum of intakes and outputs each day while inpatient, an average of 8 days
Urine Output
Time frame: preoperative measurement
Study Characteristics of Participants: Body Mass Index
Time frame: baseline measurement
American Society of Anaesthesiologists Physical Status Classification Scale
Time frame: preoperative
Amount of Intraoperative Fluids
Time frame: intraoperative measurement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Oxner, MD principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodystat Quadscan 4000 in people with Intestinal Cancer and Diverticulitis, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance Assessment (time frame: preoperative measurement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.