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

NCT01082614 | Completed Results

• 1 other identifier: 59162
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of Postoperative Hospital Stay

  time in days from end of surgery to hospital discharge

  within one month

Secondary Outcomes (2)

• Quality of Recovery Score on Postoperative Day 2

  Postoperative day 2

• Quality of Recovery Score on Postoperative Day 4

  Postoperative day 4

Study Arms (2)

Standard fluid management

NO INTERVENTION

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

Goal directed therapy

EXPERIMENTAL

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

Device: Vigileo

Interventions

Vigileo 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%.

Also known as: Vigileo model number MHM1

Goal directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Results Point of Contact

• Title: Tonya Hamilton
• Organization: Loma Linda University

thamilton@llu.edu

909-558-9408

Study Officials

• Richard L. Applegate II, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 8, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 26, 2019
• Results First Posted: April 2, 2015

Record last verified: 2019-03

Locations

US (1)