Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01467167|
Recruitment Status : Recruiting
First Posted : November 8, 2011
Last Update Posted : October 25, 2016
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||September 2017|
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.
- 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.
- Total anesthetic drug doses [ Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467167
|Contact: Athony absalom, Prof.email@example.com|
|Contact: rob firstname.lastname@example.org|
|University Medical Center Groningen (UMCG)||Recruiting|
|Contact: Anthony Absalom, MD PhD 050-3616161 ext 0031 email@example.com|
|University Hospital of Bern||Recruiting|
|Contact: Martin Luginbühl, MD PhD|