Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-02 @ 4:39 AM
Study NCT ID:
NCT04070404
Status:
UNKNOWN
Last Update Posted:
2020-10-09
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Preoxygenation in Emergency Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficient preoxygenation in preset time', 'timeFrame': '300 seconds', 'description': 'End-tidal oxygen concentration values'}], 'secondaryOutcomes': [{'measure': 'Factors influencing preoxygenation quality', 'timeFrame': '300 seconds', 'description': 'Medical history, physical status, lab findings, preoxygenation equipment and method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anaesthesia', 'Preoxygenation'], 'conditions': ['Preoxygenation', 'Anaesthesia', 'Emergencies', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.\n\nThe aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.', 'detailedDescription': 'Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.\n\nParameters analysed:\n\n* Preoperative: medical history, physical examination, laboratory findings, anthropometric data\n* Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients undergoing general anaesthesia for emergency surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* patient going for emergency surgery under general anaesthesia\n* age \\> 18 years\n\nExclusion Criteria:\n\n* informed consent refusal\n* noneligible for preoxygenation before general anaesthesia'}, 'identificationModule': {'nctId': 'NCT04070404', 'briefTitle': 'Quality of Preoxygenation in Emergency Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery', 'orgStudyIdInfo': {'id': '19BMT30'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vilnius', 'status': 'RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Egle Kontrimaviciute, Assoc. Preofessor', 'role': 'CONTACT', 'email': 'egle.kontrimaviciute@santa.lt', 'phone': '+37052365264'}, {'name': 'Ruta Januleviciene, MD', 'role': 'CONTACT', 'email': 'ruta.januleviciene2@santa.lt', 'phone': '+37052365264'}], 'facility': 'Vilnius University Hospital Santaros Clinics', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'centralContacts': [{'name': 'Egle Kontrimaviciute, Assoc Professor', 'role': 'CONTACT', 'email': 'egle.kontrimaviciute@santa.lt', 'phone': '+37052365264'}, {'name': 'Ruta Januleviciene, MD', 'role': 'CONTACT', 'email': 'ruta.januleviciene2@santa.lt', 'phone': '+37052365264'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}