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临床试验/NCT01244685
NCT01244685已完成不适用

Randomized Controlled Trial With Deltex CardioQ in Elective Bowel Resection Patients

Stony Brook University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Length of stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Length of stay

时间窗: at Discharge

Length of hospital stay from day of admission to day of discharge

次要结局

  • Determining the ideal amount of fluids to be administered(During and post surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Bergamaschi

Professor and Chief, Division of Colon and Rectal Surgery

Stony Brook University

研究点 (2)

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