Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 10:06 AM
Study NCT ID:
NCT05519969
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre Preoperative Fasting Audit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063466', 'term': 'Respiratory Aspiration of Gastric Contents'}], 'ancestors': [{'id': 'D057045', 'term': 'Laryngopharyngeal Reflux'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary aspiration', 'timeFrame': 'Intraoperative', 'description': 'The incidence of confirmed pulmonary aspiration according to the study protocol'}], 'secondaryOutcomes': [{'measure': 'Suspected pulmonary aspiration', 'timeFrame': 'Intraoperative', 'description': 'The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperation fasting', 'General anesthesia', 'Children', 'Pulmonary aspiration of gastric contents'], 'conditions': ['Pulmonary Aspiration of Gastric Contents']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34857683/', 'label': 'Pre-operative fasting in children: guideline from the European Society of Anaesthesiology and Intensive Care.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25940831/', 'label': 'Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32533888/', 'label': 'Impact of clear fluid fasting on pulmonary aspiration in children undergoing general anesthesia: Results of the German prospective multicenter observational (NiKs) study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28675597/', 'label': 'Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative ward'}]}, 'descriptionModule': {'briefSummary': 'The new European Society of Anaesthesiology and Intensive Care (ESAIC) preoperative fasting guideline recommends a one hour minimum fasting time for clear fluids. This represents a major change in the practice of pediatric anaesthesia.\n\nDuring the transition to shorter fasting times on a global scale, we need a large multicenter audit to monitor the incidence of pulmonary aspiration.', 'detailedDescription': 'The purpose of preoperative fasting is to achieve an empty stomach at the time of anaesthesia induction.\n\nMost current fasting guidelines all take into account the balance between the risk of pulmonary aspiration and the harmful effects of prolonged preoperative fasting. However, there is increased awareness among pediatric as well as general anaesthesiologists that many patients suffer from prolonged duration of fasting in spite of the reasonable nominal respective limits of 6-4-2 hours. Prolonged fasting may be harmful, especially in small children, but also in adults with a poor nutritional status.\n\nThe new European Society of Anaesthesiology and Intensive Care (ESAIC, 2022) preoperative fasting guideline recommends a one-hour minimum fasting time for clear fluids. This represents a major change in the practice of paediatric anaesthesia. During the transition to shorter fasting times on a global scale, we need a large multicentre audit to monitor the incidence of pulmonary aspiration.\n\nThe primary aim of the European Preoperative Fasting Audit (EUROFAST) is to determine the safety of reducing the required fasting time for clear fluids to at least one hour in children fasting before elective procedures requiring general anaesthesia (as recommended in the ESAIC guideline).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children less than 16 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, age \\< 16 years old\n* General anesthesia\n\nExclusion criteria\n\n* Age \\> 15 years\n* Procedure without general anesthesia\n* General anesthesia performed at center with less than 1000 pediatric cases per year'}, 'identificationModule': {'nctId': 'NCT05519969', 'acronym': 'EUROFAST', 'briefTitle': 'A Multicentre Preoperative Fasting Audit', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)', 'orgStudyIdInfo': {'id': 'EUROFAST'}}, 'armsInterventionsModule': {'armGroups': [{'label': '6-4-2 group', 'description': '\\- Cases from centres implementing the rule of a minimum of 6 hours of fasting for solids, 4 hours for breast milk and 2 hours for clear fluids before anesthesia.'}, {'label': '6-4-1 group', 'description': '\\- Cases from centres implementing the 1 hour fasting rule for clear fluids recommended by ESAIC and specified in the guideline Preoperative fasting in children'}, {'label': '6-4-0 group', 'description': '\\- Cases from centres implementing the "zero" hour clear fasting rule, which means that children are allowed intake of clear fluids until they are called to the operating room'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Peter Frykholm, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'url': 'https://www.uu.se/institution/kirurgiska-vetenskaper/forskning/anestesiologi-och-intensivvard/barnanestesi-och-perioperativ-medicin/eurofast', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From ethics approval to Dec. 31, 2023', 'ipdSharing': 'YES', 'description': 'Plan to share data on request.', 'accessCriteria': 'Official web page'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Peter Frykholm', 'investigatorAffiliation': 'Uppsala University'}}}}