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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01124474
Enrollment
5
Registered
2010-05-17
Start date
2010-12-31
Completion date
2012-04-30
Last updated
2012-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedures, Operative

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 a shorter hospital stay after surgery.

Interventions

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%.

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients scheduled for major spine surgery at LLUMC University Hospital will be eligible for participation in this study

Exclusion criteria

* age under 18yr, * coagulopathy, significant renal or hepatic dysfunction (creatinine or liver enzymes \> 50% above normal values), * congestive heart failure, * cardiac arrhythmias producing irregular rhythms, and patient refusal.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine SurgeryFrom end of surgey to approximately 1 weektime in days from the end of surgery to hospital discharge

Secondary

MeasureTime frameDescription
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgeryfrom the end of surgery to approximately 1 monthThe measure of quality of recovery using scoring system; assessed by patient and nursing team

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026