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

Surgical Procedures, Operative Clinical Trial

Official title:

Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Early Goal Directed Therapy in Patients Undergoing Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082614
• Other study ID #: 59162
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: March 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

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%.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Postoperative Hospital Stay	time in days from end of surgery to hospital discharge	within one month
Secondary	Quality of Recovery Score on 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.	Postoperative day 2
Secondary	Quality of Recovery Score on 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.	Postoperative day 4