1 Fluid ManagementNCT01244685
Trial With Deltex Cardio in Elective Bowel Resection Patients
A study testing Deltex CardioQ Probe in people with 1 Fluid Management, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is: To determine if the intraoperative fluid administration with the Deltex CardioQ esophageal Doppler will reduce the length of stay after elective bowel resection. The probe can be used to dynamically measure stroke volume and cardiac output. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 1 Fluid Management
- What is being tested?
- Deltex CardioQ Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All elective bowel resection cases, laparoscopic or open
- Age 18 or older
- Ability to consent
Who cannot join
- All emergency cases
- Inability to consent
- Esophageal or upper airway disease or recent surgery
- Moderate or severe aortic valvular disease, congestive heart failure
- Severe kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Broook University Medical Center
Stony Brook, New York, 11794-8191
About this study
Official title: Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients
The purpose of this study is:
- To determine if the intraoperative fluid administration with the Deltex CardioQ esophageal Doppler will reduce the length of stay after elective bowel resection.
- The probe can be used to dynamically measure stroke volume and cardiac output. This information will assist us in determining the ideal amount of fluids to be administered.
- To determine if the fluid administration established by the esophageal probe will result in a shorter length of stay in elective bowel resection patients.
- The investigators plan to enroll 100 patients in this study.
Read the detailed description
Intraoperative goal-directed IV fluid administration utilizing an esophageal Doppler as a guide to measuring the amount of fluid by looking into the stroke volume to determine if there is too little or too much fluid. It has been shown that inadequate fluid administration is a cause of increased morbidity and length of stay after elective bowel resection. However, there are no data evaluating the Doppler's use in the postoperative period, only intraoperatively. Our objective is to evaluate whether postoperative goal-directed fluid management with the Deltex CardioQ esophageal Doppler probe leads to shorter hospital stay in elective bowel resection patients. All consecutive patients randomized into the 'standard fluid' group and the 'goal-directed fluid' group. All will follow standard surgical postoperative care with the exception of fluid administration. If eligible, all patients will receive an epidural catheter for pain control. The 'goal-directed fluid' group will have a Deltex CardioQ probe placed nasally in the operating room by the anesthesia team, and fluid management will be administered via anesthesia protocol. The 'standard fluid' group will not receive the Deltex CardioQ probe.Patients in the 'goal-directed fluid' group will receive fluids according to body weight for the first 24 hours. The probe will be evaluated every15 minutes in the Post Anesthesia Care Unit and measurements will be taken to determine whether fluids will be given to the patient.On the surgical floor, patients in the 'goal-directed fluid' group will be evaluated every 8 hours and fluids will be given if necessary according to measurements taken via the probe.
Intraoperative goal-directed IV fluid administration utilizing an esophageal Doppler as a guide to measuring the amount of fluid by looking into the stroke volume to determine if there is too little or too much fluid. It has been shown that inadequate fluid administration is a cause of increased morbidity and length of stay after elective bowel resection. However, there are no data evaluating the Doppler's use in the postoperative period, only intraoperatively. Our objective is to evaluate whether postoperative goal-directed fluid management with the Deltex CardioQ esophageal Doppler probe leads to shorter hospital stay in elective bowel resection patients. All consecutive patients randomized into the 'standard fluid' group and the 'goal-directed fluid' group. All will follow standard surgical postoperative care with the exception of fluid administration. If eligible, all patients will receive an epidural catheter for pain control. The 'goal-directed fluid' group will have a Deltex CardioQ probe placed nasally in the operating room by the anesthesia team, and fluid management will be administered via anesthesia protocol. The 'standard fluid' group will not receive the Deltex CardioQ probe.Patients in the 'goal-directed fluid' group will receive fluids according to body weight for the first 24 hours. The probe will be evaluated every15 minutes in the Post Anesthesia Care Unit and measurements will be taken to determine whether fluids will be given to the patient.On the surgical floor, patients in the 'goal-directed fluid' group will be evaluated every 8 hours and fluids will be given if necessary according to measurements taken via the probe.
- Conditions
- 1 Fluid Management
- Being tested
- Deltex CardioQ Probe
- Keywords
- bowel resection, Deltex CardioQ Probe, fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deltex CardioQ ProbeDevice
Deltex CardioQ probe will be placed nasally in the operating room by the anesthesia team and fluid management will be administered via anesthesia protocol.
| Study group | Role | What they receive |
|---|---|---|
| probe | Active comparator | Patients in the 'goal-directed fluid' Lactated Ringers solution according to ideal body weight for the first 24 hours. The fluids will be changed after the first 24 hours and continued until the patient is tolerating a regular diet. The Deltex CardioQ esophageal probe will be evaluated every 15 minutes in the Post Anesthesia Care Unit (PACU) by the Anesthesia service. Stroke Volume (SV), Flow Time Corrected (FTc), and Peak Velocity (PV) will be measured. A short FTc (<330 ms) indicative of hypovolemia will receive a 3cc/kg fluid challenge with Lactated Ringers crystalloid solution over 5 minutes. A SV increase of >10% will receive a further 3cc/kg fluid challenge. A SV increase of <10% will not receive further fluid challenge. Receives: Device: Deltex CardioQ Probe |
| Standard Fluid | No intervention | Patients in the 'standard fluid' group will receive Lactated Ringers solution for 24 hours post-operatively at 1 times maintenance rate according to ideal body weight. Then the fluids will be changed to physiologic maintenance with D5½NS at the same rate. Fluids will be decreased by ½ once the patient is tolerating a clear liquid diet, and then discontinued once the patient is tolerating a regular diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of hospital stay from day of admission to day of discharge
Measured: at Discharge
Secondary outcomes (1)
Determining the ideal amount of fluids to be administered
- The probe can be used to dynamically measure stroke volume and cardiac output. This information will assist us in determining the ideal amount of fluids to be administered.
Measured: During and post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1 Fluid ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Bergamaschi, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244685
- Sponsor's protocol ID
- 139939
- Status last verified
- Oct 2012
- First submitted
- 18 Nov 2010
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients
- ClinicalTrials.gov ID
- NCT01244685
- Acronym / sponsor ID
- 139939
- Conditions
- 1 Fluid Management
- Keywords
- bowel resection, Deltex CardioQ Probe, fluid management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To determine if the intraoperative fluid administration with the Deltex CardioQ esophageal Doppler will reduce the length of stay after elective bowel resection.
- The probe can be used to dynamically measure stroke volume and cardiac output. This information will assist us in determining the ideal amount of fluids to be administered.
- To determine if the fluid administration established by the esophageal probe will result in a shorter length of stay in elective bowel resection patients.
- The investigators plan to enroll 100 patients in this study.
Detailed description
Intraoperative goal-directed IV fluid administration utilizing an esophageal Doppler as a guide to measuring the amount of fluid by looking into the stroke volume to determine if there is too little or too much fluid. It has been shown that inadequate fluid administration is a cause of increased morbidity and length of stay after elective bowel resection. However, there are no data evaluating the Doppler's use in the postoperative period, only intraoperatively. Our objective is to evaluate whether postoperative goal-directed fluid management with the Deltex CardioQ esophageal Doppler probe leads to shorter hospital stay in elective bowel resection patients. All consecutive patients randomized into the 'standard fluid' group and the 'goal-directed fluid' group. All will follow standard surgical postoperative care with the exception of fluid administration. If eligible, all patients will receive an epidural catheter for pain control. The 'goal-directed fluid' group will have a Deltex CardioQ probe placed nasally in the operating room by the anesthesia team, and fluid management will be administered via anesthesia protocol. The 'standard fluid' group will not receive the Deltex CardioQ probe.Patients in the 'goal-directed fluid' group will receive fluids according to body weight for the first 24 hours. The probe will be evaluated every15 minutes in the Post Anesthesia Care Unit and measurements will be taken to determine whether fluids will be given to the patient.On the surgical floor, patients in the 'goal-directed fluid' group will be evaluated every 8 hours and fluids will be given if necessary according to measurements taken via the probe.
Intraoperative goal-directed IV fluid administration utilizing an esophageal Doppler as a guide to measuring the amount of fluid by looking into the stroke volume to determine if there is too little or too much fluid. It has been shown that inadequate fluid administration is a cause of increased morbidity and length of stay after elective bowel resection. However, there are no data evaluating the Doppler's use in the postoperative period, only intraoperatively. Our objective is to evaluate whether postoperative goal-directed fluid management with the Deltex CardioQ esophageal Doppler probe leads to shorter hospital stay in elective bowel resection patients. All consecutive patients randomized into the 'standard fluid' group and the 'goal-directed fluid' group. All will follow standard surgical postoperative care with the exception of fluid administration. If eligible, all patients will receive an epidural catheter for pain control. The 'goal-directed fluid' group will have a Deltex CardioQ probe placed nasally in the operating room by the anesthesia team, and fluid management will be administered via anesthesia protocol. The 'standard fluid' group will not receive the Deltex CardioQ probe.Patients in the 'goal-directed fluid' group will receive fluids according to body weight for the first 24 hours. The probe will be evaluated every15 minutes in the Post Anesthesia Care Unit and measurements will be taken to determine whether fluids will be given to the patient.On the surgical floor, patients in the 'goal-directed fluid' group will be evaluated every 8 hours and fluids will be given if necessary according to measurements taken via the probe.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probe | Active comparator | Device: Deltex CardioQ ProbePatients in the 'goal-directed fluid' Lactated Ringers solution according to ideal body weight for the first 24 hours. The fluids will be changed after the first 24 hours and continued until the patient is tolerating a regular diet. The Deltex CardioQ esophageal probe will be evaluated every 15 minutes in the Post Anesthesia Care Unit (PACU) by the Anesthesia service. Stroke Volume (SV), Flow Time Corrected (FTc), and Peak Velocity (PV) will be measured. A short FTc (<330 ms) indicative of hypovolemia will receive a 3cc/kg fluid challenge with Lactated Ringers crystalloid solution over 5 minutes. A SV increase of >10% will receive a further 3cc/kg fluid challenge. A SV increase of <10% will not receive further fluid challenge. |
| Standard Fluid | No intervention | –Patients in the 'standard fluid' group will receive Lactated Ringers solution for 24 hours post-operatively at 1 times maintenance rate according to ideal body weight. Then the fluids will be changed to physiologic maintenance with D5½NS at the same rate. Fluids will be decreased by ½ once the patient is tolerating a clear liquid diet, and then discontinued once the patient is tolerating a regular diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All elective bowel resection cases, laparoscopic or open
- Age 18 or older
- Ability to consent
Key exclusion criteria (5 listed)
- All emergency cases
- Inability to consent
- Esophageal or upper airway disease or recent surgery
- Moderate or severe aortic valvular disease, congestive heart failure
- Severe kidney disease
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 |
|---|---|---|
| Deltex CardioQ ProbeDeltex CardioQ probe will be placed nasally in the operating room by the anesthesia team and fluid management will be administered via anesthesia protocol. | Device | probe |
Primary outcome
Length of stay
Time frame: at Discharge
Length of hospital stay from day of admission to day of discharge
1 secondary outcome
Determining the ideal amount of fluids to be administered
Time frame: During and post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deltex CardioQ Probe in people with 1 Fluid Management, run by Stony Brook University 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 3 inclusion and 5 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 5 Oct 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of stay (time frame: at Discharge). 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 5 Oct 2012.