Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-02 @ 12:30 AM
Study NCT ID:
NCT02603094
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric pH in Intubated Children - Part Two
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gastric pH', 'timeFrame': 'within 10 min after tracheal intubation', 'description': 'gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution'}], 'secondaryOutcomes': [{'measure': 'gastric aspirate volume', 'timeFrame': 'within 10 min after tracheal intubation', 'description': 'gastric aspirate volume is the amount of gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution'}, {'measure': 'subjective feeling of hunger/thirst', 'timeFrame': 'baseline', 'description': 'subjective feeling of hunger/thirst given as "yes" or "no" answer'}, {'measure': 'Postoperative Nausea and Vomiting (PONV) in recovery unit', 'timeFrame': 'recovery period, on the average within 90 minutes after end of anaesthesia'}, {'measure': 'Behaviour during recovery period', 'timeFrame': 'recovery period, on the average within 90 minutes after end of anaesthesia', 'description': 'Rating Scale1-5 by blinded nurse (5: severely agitated/emergence delir with subsequent drug therapy, 4: agitated/emergence delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)'}, {'measure': 'Behaviour during anaesthesia induction', 'timeFrame': 'on the average within 20 minutes after arrival of patient in operating theatre', 'description': 'Rating scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting'}, {'measure': "Nurse's Impression of patient's satisfactory", 'timeFrame': 'baseline', 'description': "subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4"}, {'measure': 'blood Ketone measurement', 'timeFrame': 'intraoperative', 'description': 'measurement of blood Ketone with a portable poc Ketone measurement device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preoperative Fasting']}, 'referencesModule': {'references': [{'pmid': '30115263', 'type': 'DERIVED', 'citation': 'Schmidt AR, Buehler KP, Both C, Wiener R, Klaghofer R, Hersberger M, Weiss M, Schmitz A. Liberal fluid fasting: impact on gastric pH and residual volume in healthy children undergoing general anaesthesia for elective surgery. Br J Anaesth. 2018 Sep;121(3):647-655. doi: 10.1016/j.bja.2018.02.065. Epub 2018 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk\n\nHypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage \\> 1 / \\< 16 years ASA class l or ll elective surgery requiring general anaesthesia using tracheal intubation\n\nExclusion Criteria:\n\ndisease or dysfunction of gastrointestinal tract chronic diseases or conditions not compatible with ASA class l or ll'}, 'identificationModule': {'nctId': 'NCT02603094', 'briefTitle': 'Gastric pH in Intubated Children - Part Two', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei', 'orgStudyIdInfo': {'id': 'KEK-ZH Nr. 2011-0034 Amend3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clear fluids until premedication', 'description': 'allowed to drink until premedication, aprox 30 minutes before anaesthesia induction. Fasting for solids and non-clear fluids is six hours.', 'interventionNames': ['Procedure: clear fluid ingestion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 hours fluid fasting', 'description': 'allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours.', 'interventionNames': ['Procedure: clear fluid ingestion']}], 'interventions': [{'name': 'clear fluid ingestion', 'type': 'PROCEDURE', 'description': 'drinking of clear fluid in preoperative period', 'armGroupLabels': ['2 hours fluid fasting', 'clear fluids until premedication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Childrens Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Achim J Schmitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital, Zurich"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}