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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 8, 2010
Last Update Posted: April 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Loma Linda University
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082614

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

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01082614     History of Changes
Other Study ID Numbers: 59162
First Submitted: March 3, 2010
First Posted: March 8, 2010
Results First Submitted: March 17, 2015
Results First Posted: April 2, 2015
Last Update Posted: April 2, 2015
Last Verified: March 2015