Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-24 @ 8:48 AM
Study NCT ID:
NCT06527703
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.', 'timeFrame': 'Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024', 'description': 'Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.\n\nAfter obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative fluid fasting time'], 'conditions': ['Diabetes Mellitus', 'Hypertension', 'Ischaemic Heart Disease', 'Comorbidities and Coexisting Conditions', 'Fasting', 'Fasting, Time Restricted']}, 'descriptionModule': {'briefSummary': 'The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.\n\nResearch has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.\n\nReducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.\n\nThe investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.', 'detailedDescription': 'The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. The investigators have interest and commitment from 12 countries and hope to recruit more hospitals in the coming weeks.\n\nResearch has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.\n\nIn the pilot study the investigators conducted a few weeks ago, the average preoperative liquid fasting time was 12 hours instead of the recommended 2 hours. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesise that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed. This will give further insight to colleagues and encourage healthcare professionals to follow the fasting guidelines from the European Society of Anaesthesia and Intensive Care.\n\nThe methodology and other details can be found in the study protocol and the other documents. Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres and the target date is the 23rd October 2024.\n\nAfter obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The following data will be collected:\n\nPatient Number:\n\nInformed Consent: ☐ yes ☐ no\n\nScreening for eligibility Age \\>= 18 years: ☐ yes ☐ no\n\nGender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nProcedure:\n\nGeneral surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nType of Anaesthesia (choose 1):\n\nGA ☐ Sedation ☐ Regional ☐\n\nDate and Time at which clear fluids were last consumed:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nThe questionnaire will last less than 5 minutes.\n\nThis questionnaire is very simple and no patient identifiable data will be recorded on the data collection tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.\n\nData will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.\n\nThe type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients undergoing elective surgery\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Urgent and emergency surgery'}, 'identificationModule': {'nctId': 'NCT06527703', 'acronym': 'THIRST', 'briefTitle': 'An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting', 'organization': {'class': 'OTHER', 'fullName': 'Mater Dei Hospital, Malta'}, 'officialTitle': 'International Prospective, Observational, Multi-centre, Cross-sectional Study on the Duration of Pre-operative Liquid Fasting', 'orgStudyIdInfo': {'id': 'ThirstStudy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preoperative liquid fasting duration in adult patients undergoing elective surgery', 'description': 'Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.\n\nData will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.\n\nThe type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded', 'interventionNames': ['Other: no intervention']}, {'label': 'preoperative liquid fasting time', 'description': 'Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained.\n\nData will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.\n\nThe type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'Patients have to answer a questionnaire. The following data will be recorded:\n\nPatient Number:\n\nInformed Consent: ☐ yes ☐ no\n\nScreening for eligibility Age \\>/= 18 years: ☐ yes ☐ no Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no\n\nTime of arrival in the operating room \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nProcedure:\n\nGeneral surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nType of Anaesthesia (choose 1):\n\nGA ☐ Sedation ☐ Regional ☐\n\nDate and Time at which clear fluids were last consumed:\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_', 'armGroupLabels': ['preoperative liquid fasting duration in adult patients undergoing elective surgery', 'preoperative liquid fasting time']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'STJ 3711', 'city': 'San Ġiljan', 'state': 'Msida', 'country': 'Malta', 'facility': 'Mater Dei Hospital', 'geoPoint': {'lat': 35.91839, 'lon': 14.48977}}], 'overallOfficials': [{'name': 'Federico Bilotta, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne Marie Camilleri Podesta, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mater Dei Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD The results from the study will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mater Dei Hospital, Malta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': "Anne Marie Camilleri Podesta'", 'investigatorAffiliation': 'Mater Dei Hospital, Malta'}}}}