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

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ClinicalTrials.gov Identifier: NCT01467167
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
MMRF Struys, University Medical Center Groningen

Brief Summary:
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 or disease
Anesthesia,General

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Study Start Date : October 2011
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Group/Cohort
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.



Primary Outcome Measures :
  1. Anesthesia Quality Score [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ]
    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 :
  1. Total anesthetic drug doses [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ]
  2. Mean intra-operative Noxious Stimulation Response Index (NSRI) [ Time Frame: 1 day During surgery (until skin closure) ]
    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.

  3. Number of doses of vasoactive substances [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ]
    The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.

  4. 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 ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. Workload of anesthesist, measured by the NASA Taskload Index [ Time Frame: up to 1 day From start of induction until transportation to PACU ]
    Assess the workload the anesthetist experiences while working with the Smart Pilot View



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467167


Locations
Netherlands
University Medical Center Groningen (UMCG)
Groningen, Netherlands
Switzerland
University Hospital of Bern
Bern, Switzerland
Sponsors and Collaborators
MMRF Struys
University Hospital Inselspital, Berne

Responsible Party: MMRF Struys, Prof.dr, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01467167     History of Changes
Other Study ID Numbers: SPV_Utility_V7
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by MMRF Struys, University Medical Center Groningen:
Anesthesia
Smart Pilot View
Pain control
Recovery