Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT03451604
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2018-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PAC Time Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total time involved in preoperative anesthesia consultation (min)', 'timeFrame': '30 min', 'description': 'total time (min) is defined by the time between patient entry and discharge from the consultation office. It integrates time for patient assessment (this encompasses a medical history and physical examination) and time for patient information on the benefits and risks of the chosen anesthetic strategy (patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent)'}], 'secondaryOutcomes': [{'measure': 'anesthesia and surgery information and patient demographics', 'timeFrame': '30 min', 'description': 'Data included anesthesia and surgery information and patient demographics\n\n* ASA status\n* Age\n* BMI\n* In patient or outpatient\n* Number of medication\n* Number of co morbidity\n* Socioeconomic level\n* Surgical specialty\n* Senior or resident anesthesiologist (year experience)\n* Preoperative anxiety between 0 and 10\n* Patient satisfaction between 0 and 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Assessment Time']}, 'descriptionModule': {'briefSummary': "The aim of the preoperative assessment clinic (PAC) is to ensure optimal anaesthesia, reduce the morbidity associated with surgery, to increase the quality and decrease the cost of perioperative care 1. In addition, the PAC is an appropriate time to educate the patient on anaesthesia, perioperative care, and pain treatments, to reduce anxiety, to develop care plans, and to obtain informed consent. Moreover, a strong correlation exists between the time spent at the PAC and patient satisfaction2,3.\n\nA high variability of preoperative assessment clinic (PAC) times is a reason for waiting time for patient. A better match between the reserved PAC time and the real consultation time could improved efficiency in consultation theatre. The PAC time depends on various parameters. On average the preoperative assessment of patients with a higher American Society Anesthesiologists' (ASA) class requires more time 4. In other monocentric study, the mean (SD) procedure time was 13 (6) min for the physician. It was significantly longer for patients with a higher ASA class : 10 min for ASA I, 14 min for ASA II, 17 min for ASA III and 21 min for ASA IV patients. In this monocentric study, every patient had a nurse consultation before PAC by the anesthesiologist.\n\nThe primary endpoint of this study was to assess the time involved in preoperative assessment clinic included the time during patient's health status has to be assessed (this encompasses a medical history and physical examination) and the time during the patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo elective surgery under general or regional anaesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients scheduled to undergo elective surgery under general or regional anaesthesia\n\nExclusion Criteria\n\n* patients under 16 years of age\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT03451604', 'briefTitle': 'PAC Time Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Time Involved in Patient Information During Preoperative Assessment Clinic and Ratio Between Evaluation and Information Times', 'orgStudyIdInfo': {'id': 'E2016-74'}}, 'armsInterventionsModule': {'interventions': [{'name': 'preoperative assessement', 'type': 'OTHER', 'description': 'All data concerning study, involved in normal care of patient for his anesthesia (non interventional study), where included in anonymous computerized database by anesthesiologist during pre operative clinic.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent COMPERE, Pr', 'role': 'CONTACT', 'email': 'vincent.compere@chu-rouen.fr', 'phone': '033 617445203'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Vincent COMPERE', 'investigatorAffiliation': 'University Hospital, Rouen'}}}}