Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 7:10 PM
Study NCT ID:
NCT05743803
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting time', 'timeFrame': 'Before surgery', 'description': 'Liquid and solid fasting time before surgery (minutes)'}], 'secondaryOutcomes': [{'measure': 'Preoperative oral carbohydrate loading', 'timeFrame': '2 hours preoperative period', 'description': 'Rate of oral cardbohydrate intake in the 2 hours preoperative period (percentage)'}, {'measure': 'Fasting exceeding 12 hours', 'timeFrame': 'Before surgery', 'description': 'Rate of fasting duration superior to 12 hours (liquid or solid) (percentage)'}, {'measure': 'Preoperative anxiety', 'timeFrame': 'Before surgery', 'description': 'Scale of preoperative anxiety from 0 (no anxiety) to 10 (maximum anxiety possible)'}, {'measure': 'Preoperative discomfort', 'timeFrame': 'Before surgery', 'description': 'Scale of preoperative disomfort from 0 (no discomfort) to 10 (maximum discomfort possible)'}, {'measure': 'Feeling of thirst', 'timeFrame': 'Before surgery', 'description': 'Qualitative scale of preoperative thirst (none, moderate, significant)'}, {'measure': 'Feeling of hunger', 'timeFrame': 'Before surgery', 'description': 'Qualitative scale of preoperative hunger (none, moderate, significant)'}, {'measure': 'Preoperative nausea or vomiting', 'timeFrame': 'Before surgery', 'description': 'Rate of nausea or vomit in the preoperative period (percentage)'}, {'measure': 'Rate of postoperative nausea or vomiting', 'timeFrame': 'Day of surgery', 'description': 'Rate of nausea or vomit during the post-operative period (percentage)'}, {'measure': 'Patient satisfaction toward communication and explanation about preoperative fasting.', 'timeFrame': 'Day of surgery', 'description': 'Binary answer (yes or no)'}, {'measure': 'Post-operative quality of recovery', 'timeFrame': 'Day 1 after surgery', 'description': 'French Quality of Recovery 15 score ('}, {'measure': 'Length of stay', 'timeFrame': 'Maximum 30 days follow up', 'description': 'Length of stay (days)'}, {'measure': 'Post-operative surgical complication', 'timeFrame': 'Maximum 30 days follow up', 'description': 'Clavien-dindo classification from 0 (no complication) to 5 (death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting', 'quality of recovery', 'surgery'], 'conditions': ['Fasting']}, 'descriptionModule': {'briefSummary': 'The goal of this before and after observational study is to evaluate the impact of a global sensitization campaign (targeted on surgeons, anesthetist and patients) about pre-operative fasting in an adult population. The main questions it aims to answer are:\n\n* Does the sensitization campaign reduce fasting time?\n* Does reduce fasting time increase quality of post-operative recovery?\n\nSensitization campaign will be performed between the before and after phases, it will include:\n\n* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.\n* Reminder display in surgical wards and consults.\n* Individualized fasting cards for patients.\n* Short message service reminder on pre-operative fasting rules for patients.\n* Medical fasting prescription with clear fasting times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult undergoing a surgical procedure.\n\nExclusion Criteria:\n\n* Already intubated patient before surgery.\n* Redo surgery during the same hospitalization\n* Medical indication of fasting (e.g : occlusive syndrome)\n* Patient unable to anwser the questionnaire.\n* Patient under lawful protection\n* Pregnant women\n* Minor (\\<18 years)'}, 'identificationModule': {'nctId': 'NCT05743803', 'acronym': 'BreakFast', 'briefTitle': 'Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Preoperative Fasting Guidelines Study', 'orgStudyIdInfo': {'id': '2023-AR23_00060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before', 'description': 'This group will undergo their preoperative fasting period as standard care.'}, {'label': 'After', 'description': 'This group will undergo their preoperative fasting period after the sensitization campaign about preoperative fasting rules.', 'interventionNames': ['Other: Sensititization campaign on preoperative fasting rules']}], 'interventions': [{'name': 'Sensititization campaign on preoperative fasting rules', 'type': 'OTHER', 'description': '* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.\n* Reminder display in surgical wards and consults.\n* Individualized fasting cards for patients.\n* Short message service reminder on pre-operative fasting rules for patients.\n* Medical fasting prescription with clear fasting times.', 'armGroupLabels': ['After']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}