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Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Medical Centre Groningen
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01467167
First received: September 14, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.


Condition
Depth of Anesthesia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Anesthesia Quality Score [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
    Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg.


Secondary Outcome Measures:
  • Total anesthetic drug doses [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
  • Mean intra-operative Noxious Stimulation Response Index (NSRI) [ Time Frame: 1 day During surgery (until skin closure) ] [ Designated as safety issue: No ]
    The Noxious Stimulation Response Index (NSRI) is based on a hierarchical interaction propofol-remifentanil model. With this model, the predicted propofol and remifentanyl concentrations can make a prediction about a respons to a certain stimulus, such as shaking and shouting, or a noxious stimulus.

  • Number of doses of vasoactive substances [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
    The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.

  • Number of events with motor and vegetative (tearing, sweating) responses [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit ] [ Designated as safety issue: No ]
    The total number of events in which the patient displays vegetative reactions such as tearing and sweating, in respons to a noxious stimulus during surgery.

  • Recovery times (skin closure to extubation; skin closure to orientation) [ Time Frame: up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
    The time it takes for the patient to recover from anesthesia: the time from skin closure until the patient is sufficiently awake to be extubated, and the time from skin closure until full orientation of the patient.

  • Early postoperative pain control measured by visual analog scale and total morphine dose [ Time Frame: up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
    Assess the adequacy of pain control during the early postoperative stage, measured by the visual analog scale and the total dose of morphine immediately postoperatively and during PACU stay.

  • Workload of anesthesist, measured by the NASA Taskload Index [ Time Frame: up to 1 day From start of induction until transportation to PACU ] [ Designated as safety issue: No ]
    Assess the workload the anesthetist experiences while working with the Smart Pilot View


Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Baseline
Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice.
Smart Pilot View Group
Study group in which patients are anesthetized with the use of Smart Pilot View.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.

Criteria

Inclusion Criteria:

  • Elective surgery
  • General anesthesia
  • American Society of Anesthesiologists Physical Status: I - III
  • Age 18 to 90 years

Exclusion Criteria:

  • Combined regional and general anesthesia
  • Expected surgery duration < 30 minutes
  • Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
  • Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
  • Heart surgery on cardio-pulmonary bypass
  • Relevant hepatic disease (Child B or higher)
  • BMI >35
  • Overt signs of alcohol abuse
  • Contraindications or allergies to drugs used in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467167

Contacts
Contact: Athony absalom, Prof.dr a.r.absalom@umcg.nl
Contact: rob spanjersberg r.spanjersberg@umcg.nl

Locations
Netherlands
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands
Contact: Anthony Absalom, MD PhD    050-3616161 ext 0031    a.r.absalom@umcg.nl   
Switzerland
University Hospital of Bern Recruiting
Bern, Switzerland
Contact: Martin Luginbühl, MD PhD         
Sponsors and Collaborators
MMRF Struys
University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: MMRF Struys, Prof.dr, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01467167     History of Changes
Other Study ID Numbers: SPV_Utility_V7
Study First Received: September 14, 2011
Last Updated: December 9, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Anesthesia
Smart Pilot View
Pain control
Recovery

ClinicalTrials.gov processed this record on November 20, 2014