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NCT Number: NCT01082614

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

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.

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Key information

Conditions

Surgical Procedures, Operative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%.

Other names: Vigileo model number MHM1

Primary outcomes

  1. Length of Postoperative Hospital Stay

    Time frame: within one month

    time in days from end of surgery to hospital discharge

Secondary outcomes

  1. Quality of Recovery Score on Postoperative Day 2

    Time frame: 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.

  2. Quality of Recovery Score on Postoperative Day 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2010
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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