Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-02-23 @ 5:31 AM
Study NCT ID:
NCT01467167
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2011-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2011-09-14', 'studyFirstSubmitQcDate': '2011-11-03', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anesthesia Quality Score', 'timeFrame': 'up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Total anesthetic drug doses', 'timeFrame': 'up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)'}, {'measure': 'Mean intra-operative Noxious Stimulation Response Index (NSRI)', 'timeFrame': '1 day During surgery (until skin closure)', 'description': '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.'}, {'measure': 'Number of doses of vasoactive substances', 'timeFrame': 'up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)', 'description': 'The number of doses of vasoactive substances given to maintain an adequate perfusion pressure.'}, {'measure': 'Number of events with motor and vegetative (tearing, sweating) responses', 'timeFrame': 'up to 1 week From start of induction until discharge from post-anesthesia care unit', 'description': '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.'}, {'measure': 'Recovery times (skin closure to extubation; skin closure to orientation)', 'timeFrame': 'up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)', 'description': '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.'}, {'measure': 'Early postoperative pain control measured by visual analog scale and total morphine dose', 'timeFrame': 'up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)', 'description': '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.'}, {'measure': 'Workload of anesthesist, measured by the NASA Taskload Index', 'timeFrame': 'up to 1 day From start of induction until transportation to PACU', 'description': 'Assess the workload the anesthetist experiences while working with the Smart Pilot View'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Smart Pilot View', 'Pain control', 'Recovery'], 'conditions': ['Anesthesia,General']}, 'referencesModule': {'references': [{'pmid': '35361490', 'type': 'DERIVED', 'citation': 'Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* General anesthesia\n* American Society of Anesthesiologists Physical Status: I - III\n* Age 18 to 90 years\n\nExclusion Criteria:\n\n* Combined regional and general anesthesia\n* Expected surgery duration \\< 30 minutes\n* Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)\n* Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)\n* Heart surgery on cardio-pulmonary bypass\n* Relevant hepatic disease (Child B or higher)\n* BMI \\>35\n* Overt signs of alcohol abuse\n* Contraindications or allergies to drugs used in the study'}, 'identificationModule': {'nctId': 'NCT01467167', 'briefTitle': 'Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study', 'orgStudyIdInfo': {'id': 'SPV_Utility_V7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Baseline', 'description': 'Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice.'}, {'label': 'Smart Pilot View Group', 'description': 'Study group in which patients are anesthetized with the use of Smart Pilot View.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen (UMCG)', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}