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Trial With Deltex Cardio in Elective Bowel Resection Patients

Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01244685
Enrollment
58
Registered
2010-11-19
Start date
2010-03-31
Completion date
2011-11-30
Last updated
2012-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1 Fluid Management

Keywords

bowel resection, Deltex CardioQ Probe, fluid management

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.

Interventions

DEVICEDeltex CardioQ Probe

Deltex CardioQ probe will be placed nasally in the operating room by the anesthesia team and fluid management will be administered via anesthesia protocol.

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of stayat DischargeLength of hospital stay from day of admission to day of discharge

Secondary

MeasureTime frameDescription
Determining the ideal amount of fluids to be administeredDuring and post surgery• 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026