Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-27 @ 11:59 PM
Study NCT ID:
NCT02556658
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2015-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicted Level of General Anaesthesia in Hip Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-15', 'studyFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time spent in the "appropriate anaesthesia zone"', 'timeFrame': 'participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery', 'description': 'The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg'}], 'secondaryOutcomes': [{'measure': 'Dose of propofol', 'timeFrame': 'participants will be followed for the duration anesthesia, an expected average of 5 hours'}, {'measure': 'Dose of sufentanil', 'timeFrame': 'participants will be followed for the duration anesthesia, an expected average of 5 hours'}, {'measure': 'Time to extubation', 'timeFrame': 'end of anaesthesia'}, {'measure': '"NASA Task Load Index"', 'timeFrame': 'participants will be followed for the duration anesthesia, an expected average of 5 hours'}, {'measure': 'Morphine consumption', 'timeFrame': 'participants will be followed for the duration in recovery room, an expected average of 24 hours'}, {'measure': 'Incidence of awareness with recall during anaesthesia', 'timeFrame': 'postoperative day 1'}, {'measure': '"Postoperative Quality Recovery Scale"', 'timeFrame': 'during recovery room (an expected average of 24 hours) and postoperative days 1 and 3'}, {'measure': 'Length of stay', 'timeFrame': 'postoperative day 30'}, {'measure': 'Mortality', 'timeFrame': 'postoperative day 30'}]}, 'conditionsModule': {'keywords': ['Smartpilot View', 'Hip fracture surgery', 'Depth of anaesthesia', 'Intraoperative hypotension', 'Quality of anaesthesia'], 'conditions': ['Hip Fracture Surgery']}, 'referencesModule': {'references': [{'pmid': '29028921', 'type': 'RESULT', 'citation': 'Leblanc D, Conte M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chretien JM, Rony L, Rineau E, Lasocki S. SmartPilot(R) view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing hip fracture surgery under general anaesthesia\n* Age ≥ 18 years old\n* ASA classification 1, 2 or 3\n\nExclusion Criteria:\n\n* Patient not insured by a social security scheme\n* Adult patient under tutorship or curatorship\n* Age over 18 years old or under 90 years old\n* Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm\n* Body mass index \\> 35\n* Contraindication to one or more anaesthetics used in the study\n* Pregnancy or breastfeeding\n* Unweaned alcoholism\n* ASA classification 4 or 5\n* Patient undergoing hip fracture surgery under spinal anaesthesia'}, 'identificationModule': {'nctId': 'NCT02556658', 'acronym': 'NAPfem', 'briefTitle': 'Predicted Level of General Anaesthesia in Hip Fracture Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Predicted Level of General Anaesthesia in Hip Fracture Surgery', 'orgStudyIdInfo': {'id': '2014-A01243-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartpilot View group', 'description': 'General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.', 'interventionNames': ['Device: General anesthesia managed by the Smartpilot® View']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.', 'interventionNames': ['Device: General anesthesia managed without the Smartpilot® View']}], 'interventions': [{'name': 'General anesthesia managed by the Smartpilot® View', 'type': 'DEVICE', 'description': 'General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.', 'armGroupLabels': ['Smartpilot View group']}, {'name': 'General anesthesia managed without the Smartpilot® View', 'type': 'DEVICE', 'description': 'General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'University Hospital Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Mathieu CONTE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}