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

Loma Linda University (LLU)

Status: Completed

Conditions: Surgical Procedures, Operative

Treatments: Device: Vigileo

Study type: Interventional

Funder types: Other

Identifiers

NCT01082614

59162

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Standard fluid management

No Intervention group

Description:

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

Goal directed therapy

Experimental group

Description:

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

Treatment:

Device: Vigileo