Trial With Deltex Cardio in Elective Bowel Resection Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Bergamaschi, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01244685
First received: November 18, 2010
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
1 Fluid Management
Device: Deltex CardioQ Probe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Length of stay [ Time Frame: at Discharge ] [ Designated as safety issue: No ]
    Length of hospital stay from day of admission to day of discharge


Secondary Outcome Measures:
  • Determining the ideal amount of fluids to be administered [ Time Frame: During and post surgery ] [ Designated as safety issue: No ]
    • 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.


Enrollment: 58
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: probe
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.
Device: Deltex 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.
Other Name: Deltex CardioQ probe
No Intervention: Standard Fluid
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244685

Locations
United States, New York
Stony Broook University Medical Center
Stony Brook, New York, United States, 11794-8191
Sponsors and Collaborators
Stony Brook University
  More Information

No publications provided

Responsible Party: Roberto Bergamaschi, Professor and Chief, Division of Colon and Rectal Surgery, Stony Brook University
ClinicalTrials.gov Identifier: NCT01244685     History of Changes
Other Study ID Numbers: 139939
Study First Received: November 18, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
bowel resection
Deltex CardioQ Probe
fluid management

ClinicalTrials.gov processed this record on July 29, 2014