Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04787133
Status:
WITHDRAWN
Last Update Posted:
2022-09-01
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supervised Nurse Assisted Preoperative Assessment (SNAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'budgetary reason', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of patient satisfaction with a perioperative anesthetic evaluation', 'timeFrame': '48 hours', 'description': 'Patient satisfaction will be assess within 48h after surgery using the "Evaluation du Vécu de l\'Anesthésie" or "EVAN" (EVAN-G for EVAN-General anesthesia or EVAN-LR for EVAN-locoregional anesthesia).\n\nThe EVAN-G includes 26 items; six specific scores (Attention, Information, Discomfort, Privacy, Waiting and Pain) and one global index score. The EVAN-LR comprises 19 items; five specific scores (Attention, Information, Discomfort, Waiting, and Pain) and one global index score.\n\nSpecific and global index scores were linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 indicating the worst.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia consultation', 'Patient satisfaction'], 'conditions': ['Satisfaction, Patient', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone).', 'detailedDescription': 'Preoperative anesthesia consultations (PACs) are a key moment in the perioperative care journey. During the PAC, the doctor assesses the patient\'s state of health (allowing an assessment of the perioperative risk), establishes the anesthesia protocol and writes the preoperative prescriptions. PAC also helps inform and educate patients to reduce their anxiety.\n\nIndeed, if the perioperative care pathway and the risks associated with anesthesia are poorly understood, there is an increased risk of preoperative anxiety, poor compliance with preoperative prescriptions, and therefore potential cancellation of the surgical intervention.\n\nIn many countries, preoperative PACs are performed by nurses trained and supervised by anesthetists. These PACs take longer than a consultation carried out by a doctor alone, but would on the one hand have a positive effect on patient education and, on the other hand, ultimately reduce the time and costs associated with the PAC . On the other hand, the impact of PACs performed by nurses supervised by physicians on the perioperative experience of patients and on the rate of cancellations of scheduled interventions has not yet been demonstrated.\n\nSince 2013, so-called "optimized" consultations (PAC carried out by a state-certified nurse - IDE - supervised by an anesthesiologist) have been carried out at the Adolphe de Rothschild Foundation (Paris), for patients having a scheduled surgery intervention. cataract under locoregional or general anesthesia. First, the IDE collects the patient\'s history and treatments and informs him of the perioperative care pathway. In a second step, the doctor performs the pre-anesthetic medical examination, completes the medical examination and writes the appropriate pre and postoperative prescriptions. This method of consultation made it possible to optimize medical time while providing complete, even better, information to the patient.\n\nThat is why optimized PACs may improve the patient\'s perioperative experience and reduce preoperative cancellations regardless of the type of surgery. programmed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who will have an anesthesia consultation on one of the randomized shifts', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old\n* Must benefit from an anesthesia consultation for general or regional anesthesia for scheduled surgery, whatever it is.\n* Express consent to participate in the study\n* Affiliate or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient benefiting from a legal protection measure\n* Pregnant or breastfeeding woman\n* Patient unable to understand and read French, as well as to complete a self-administered questionnaire\n* Patient with mental retardation with impaired judgment'}, 'identificationModule': {'nctId': 'NCT04787133', 'acronym': 'SNAP', 'briefTitle': 'Supervised Nurse Assisted Preoperative Assessment (SNAP)', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Assessment of the Perioperative Experience of Patients According to Different Preoperative Anesthesia Consultation (PAC) Modalities', 'orgStudyIdInfo': {'id': 'JDS_2020_29'}}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Fondation Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}