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

NCT ID: NCT01082614

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-09-30

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.

Conditions

Surgical Procedures, Operative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard fluid management

standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team

Group Type: NO_INTERVENTION

No interventions assigned to this group

Goal directed therapy

Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis

Group Type: EXPERIMENTAL

Vigileo

Intervention Type: DEVICE

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%.

Interventions

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%.

Intervention Type: DEVICE

Other Intervention Names

Vigileo model number MHM1

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Davinder Ramsingh, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard L. Applegate II, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

59162

Identifier Type: -

Identifier Source: org_study_id