Clinical trial NCT01244685: Trial With Deltex Cardio in Elective Bowel Resection Patients
Official title: Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 1 Fluid Management
Keywords: bowel resection
Deltex CardioQ Probe
fluid management
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* All elective bowel resection cases, laparoscopic or open
* Age 18 or older
* Ability to consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Length of stay
timeFrame: at Discharge
Secondary outcomes:
measure: Determining the ideal amount of fluids to be administered
timeFrame: During and post surgery
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Broook University Medical Center
state: New York
Study officials:
References: