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

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.
 
ClinicalTrials.gov Identifier: NCT01082614
Recruitment Status : Completed
First Posted : March 8, 2010
Results First Posted : April 2, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Procedures, Operative Device: Vigileo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Length of Postoperative Hospital Stay [ Time Frame: within one month ]
    time in days from end of surgery to hospital discharge


Secondary Outcome Measures :
  1. Quality of Recovery Score on Postoperative Day 2 [ Time Frame: Postoperative day 2 ]
    Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery.

  2. Quality of Recovery Score on Postoperative Day 4 [ Time Frame: Postoperative day 4 ]
    Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Richard L. Applegate II, MD Loma Linda University
More Information
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Responsible Party: Davinder Ramsingh, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01082614    
Other Study ID Numbers: 59162
First Posted: March 8, 2010    Key Record Dates
Results First Posted: April 2, 2015
Last Update Posted: March 26, 2019
Last Verified: March 2019