Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07488468
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative fasting time (clear liquids and solids)', 'timeFrame': 'At anesthesia induction.', 'description': 'Time interval between last intake of clear liquids and anesthesia induction. Time interval between last solid meal and anesthesia induction.'}, {'measure': 'PACU length of stay', 'timeFrame': 'PACU admission to discharge.', 'description': 'PACU length of stay'}], 'secondaryOutcomes': [{'measure': 'Preoperative fasting time (clear liquids and solids)', 'timeFrame': 'At anesthesia induction (pre vs post implementation periods).', 'description': 'Time interval between last intake of clear liquids and anesthesia induction. Time interval between last solid meal and anesthesia induction.'}, {'measure': 'Patient satisfaction regarding fasting', 'timeFrame': 'immediately after the intervention/procedure/surgery up to 1 day postoperatively', 'description': 'Patient satisfaction regarding fasting (questionnaire)'}, {'measure': 'Perioperative complications', 'timeFrame': 'Intraoperative and immediate postoperative period (PACU).', 'description': 'Perioperative complications (e.g., nausea, vomiting, regurgitation/aspiration)'}, {'measure': 'Postoperative pulmonary and gastrointestinal complications', 'timeFrame': 'During the hospital stay up to 30 days', 'description': 'Pneumonia,Aspiration, nausea and vomiting'}, {'measure': 'Delirium occurrence', 'timeFrame': 'During the hospital stay, up to 30 days', 'description': 'Occurance of postoperative delir'}, {'measure': 'Hospital length of stay and in-hospital mortality', 'timeFrame': 'Until hospital discharge / up to 30 days', 'description': 'Hospital length of stay and in-hospital mortality'}, {'measure': 'Acute kidney injury (AKI)', 'timeFrame': 'Within the first 3 postoperative days.', 'description': 'Acute kidney injury (AKI) (creatinine increase)'}, {'measure': 'ICU/IMC admission', 'timeFrame': 'During the hospital stay up to 30 days', 'description': 'ICU/IMC admission (planned/unplanned) and duration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative fasting', 'clear liquids', 'quality improvement'], 'conditions': ['Preoperative Fasting', 'Perioperative Patient Comfort / Quality of Care', 'Postoperative Nausea and Vomiting (PONV)', 'Postoperative Pulmonary Complications', 'Delirium']}, 'descriptionModule': {'briefSummary': 'This single-center quality improvement project evaluates preoperative fasting times before elective procedures requiring anesthesiology care. The project aims to reduce prolonged fasting for clear fluids by implementing a local standard operating procedure (SOP) allowing patients to drink clear liquids until being called to the operating room ("drink until called"), supported by staff education and fasting instruction cards. Fasting times and selected perioperative outcomes will be assessed before and after implementation.', 'detailedDescription': 'Traditionally, surgical patients are instructed to fast for prolonged periods to reduce the risk of pulmonary aspiration. International guidelines recommend fasting from clear liquids for 2 hours prior to elective procedures, yet real-world fasting often extends to 6-10 hours, which can impair patient well-being and may contribute to complications such as dehydration, hypoglycemia, postoperative nausea and vomiting, and delirium-particularly in older or frail patients. This quality improvement project follows the Plan-Do-Study-Act (PDSA) framework.\n\nPlan: Review evidence and decide to implement "drink until called to the OR." Do: Train anesthesiology staff, adapt local SOPs, provide oral patient instructions, and introduce fasting instruction cards for patients and staff.\n\nStudy: Record and analyze fasting times and fluid intake prior to anesthesia induction; assess effectiveness and adjust strategies.\n\nAct: Add further staff education, posters, and short instructional screencasts to reinforce the updated fasting guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all patients undergoing elective procedures requiring anesthesiology care (general anesthesia, regional anesthesia, sedation, or anesthesiology standby) at University Hospital Giessen during the predefined pre- and post-implementation data collection periods. Patients who are already sedated, intubated, and mechanically ventilated at the time of anesthesia induction are excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients elective surgery or intervention requiring with anesthesiology care general anesthesia, regional anesthesia, sedation, or anesthesiology stand-by\n\nExclusion Criteria:\n\n* Already sedated, intubated, and mechanically ventilated patients'}, 'identificationModule': {'nctId': 'NCT07488468', 'briefTitle': 'Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures', 'orgStudyIdInfo': {'id': 'AZ 178/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'before implementation new fasting time program'}, {'label': 'Intervention group', 'description': 'after implementation a new fasting time program'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35390', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Sander, PhD', 'role': 'CONTACT', 'phone': '+4964198544401'}, {'name': 'Marit Habicher, Dr.', 'role': 'CONTACT'}], 'facility': 'Justus Liebig University Giessen, University Hospital Giessen and Marburg', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'centralContacts': [{'name': 'Marit Habicher, Dr.', 'role': 'CONTACT', 'email': 'Marit.Habicher@chiru.med.uni-giessen.de', 'phone': '+4964198544401'}, {'name': 'Brigitte Clausen', 'role': 'CONTACT', 'email': 'Brigitte.Clausen@chiru.med.uni-giessen.de'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}