Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01244685 |
| Other study ID # |
139939 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 18, 2010 |
| Last updated |
October 3, 2012 |
| Start date |
March 2010 |
| Est. completion date |
November 2011 |
Study information
| Verified date |
October 2012 |
| Source |
Stony Brook University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
