Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01082614
First received: March 3, 2010
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with shorter hospital stay after surgery.


Condition Intervention
Surgical Procedures, Operative
Device: Vigileo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Early Goal Directed Therapy in Patients Undergoing Major Abdominal Surgery

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • length of postoperative hospital stay [ Time Frame: within one month ] [ Designated as safety issue: No ]
    time in days from end of surgery to hospital discharge


Secondary Outcome Measures:
  • Quality of recovery score [ Time Frame: From end of surgery to within one month ] [ Designated as safety issue: No ]
    Measure of quality of recovery using scoring system; assessed by patient and nursing team


Enrollment: 46
Study Start Date: August 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard fluid management
standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
Experimental: Goal directed therapy
Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Device: Vigileo
Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%.
Other Name: Vigileo model number MHM1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients requiring elective or semi-elective major abdominal surgery will be assessed for eligibility.

Exclusion Criteria:

  • Age under 18 years old,
  • Coagulopathy,
  • Significant renal/hepatic dysfunction (creatine >50% or liver enzymes > 50% of normal values),
  • Congestive heart failure,
  • Cardiac arrhythmias producing irregular rhythms, and
  • Patient choice.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082614

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Richard L. Applegate II, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Richard Applegate, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01082614     History of Changes
Other Study ID Numbers: OSR#59162
Study First Received: March 3, 2010
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014