Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Verified December 2013 by University Medical Centre Groningen
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
First received: September 14, 2011
Last updated: December 9, 2013
Last verified: December 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.
- Elective surgery
- General anesthesia
- American Society of Anesthesiologists Physical Status: I - III
- Age 18 to 90 years
- 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
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
|University Medical Center Groningen (UMCG)
|Groningen, Netherlands |
|Contact: Anthony Absalom, MD PhD 050-3616161 ext 0031 email@example.com |
|University Hospital of Bern
|Bern, Switzerland |
|Contact: Martin Luginbühl, MD PhD |
University Hospital Inselspital, Berne
No publications provided
||MMRF Struys, Prof.dr, University Medical Centre Groningen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2011
||December 9, 2013
||Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by University Medical Centre Groningen:
ClinicalTrials.gov processed this record on September 18, 2014
Smart Pilot View