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

September 14, 2011
December 9, 2013
October 2011
August 2014   (final data collection date for primary outcome measure)
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.
Anesthesia Quality Score [ Time Frame: 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.
Complete list of historical versions of study NCT01467167 on ClinicalTrials.gov Archive Site
  • 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
  • Total anesthetic drug doses [ Time Frame: 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: 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: 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: 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: 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: 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: 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
Not Provided
Not Provided
 
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Depth of Anesthesia
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Athony absalom, Prof.dr a.r.absalom@umcg.nl
Contact: rob spanjersberg r.spanjersberg@umcg.nl
Netherlands,   Switzerland
 
NCT01467167
SPV_Utility_V7
No
MMRF Struys, University Medical Centre Groningen
MMRF Struys
University Hospital Inselspital, Berne
Not Provided
University Medical Centre Groningen
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP