Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Condition: Esophageal Diseases; Gastrointestinal Diseases; Disorder of the Genitourinary System; Gynecologic Diseases; Kidney Diseases; Liver Diseases; Pancreatic Diseases; Prostate Cancer; Spinal Disease
MeSH terms: Spinal Diseases; Liver Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pancreatic Diseases; Esophageal Diseases; Kidney Diseases; Genital Diseases, Female; Urogenital Diseases
Intervention: Vigileo Monitor; FloTrac Sensor
Intervention description: Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.; Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Perioperative Therapy; Perioperative Hydration; Arterial Pressure Based Cardiac Output; Vigileo Monitor; FloTrac Sensor; Fluid Volume; APCO

Summary:

      The purpose of this study is to determine whether the early identification and more precise
      intervention of operating room (OR) patient fluid administration optimization using arterial
      pressure-based cardiac output (APCO) yields comparable patient outcome as fluid
      administration optimization using a global standard care method.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is in hospital for study indicated treatment.

          2. Patient is able to comply with the study procedure.

          3. Patient must require an indwelling radial or a femoral artery catheter.

          4. Patients with an American Society of Anesthesiologists Risk Score >= 3.

          5. Lee Risk Index >/= 2 (Hypertension and Pre-diabetic metabolic state).

          6. Patient must be 40 kg or heavier.

          7. Patient has consented to be in the trial.

          8. Patient's height and weight can be accurately obtained prior to study start.

          9. Patient's ability to undergo major surgery with an anticipated blood loss > 500 ml.

        Exclusion Criteria:

          1. Patients with contraindications for the placement of radial, femoral, or other
             arterial cannula.

          2. Patients with contraindications for the placement of central venous cannula.

          3. Patients being treated with an intra-aortic balloon pump.

          4. Patients with aortic valve regurgitation.

          5. Patients with atrial fibrillation.

          6. Female patients with a known pregnancy confirmed by urine pregnancy test.

          7. Patient is currently participating in an investigational drug or another device study
             that has not completed the primary endpoint or that clinically interferes with the
             study endpoints.