Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-05 @ 10:51 AM
Study NCT ID:
NCT06718361
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen levels', 'timeFrame': 'From the initiation of oxygen therapy at the start of anesthesia induction until the completion of oxygen therapy at the end of the procedure (ranging from 30 minutes to 6 hours), oxygen concentration will be assessed continuously.', 'description': 'The oxygen levels in percentage'}], 'secondaryOutcomes': [{'measure': 'Normal oxygen levels after the end of oxygen therapy', 'timeFrame': 'From the end of oxygen therapy at the completion of procedure until the reappearance of normal oxygen levels (21%), assessed continuously, up to 10 minutes.', 'description': 'Time till the normal level of oxygen is reached after the end of oxygen therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxygen', 'concentration of oxygen', 'risk of fire', 'airway management'], 'conditions': ['Oxygen Delivery', 'Intubation', 'Airway Control', 'Concentration']}, 'referencesModule': {'references': [{'pmid': '9771170', 'type': 'BACKGROUND', 'citation': 'Robertshaw H, McAnulty G. Ambient oxygen concentrations during simulated cardiopulmonary resuscitation. Anaesthesia. 1998 Jul;53(7):634-7. doi: 10.1046/j.1365-2044.1998.410-az0512.x.'}, {'pmid': '12949302', 'type': 'BACKGROUND', 'citation': 'Theodorou AA, Gutierrez JA, Berg RA. Fire attributable to a defibrillation attempt in a neonate. Pediatrics. 2003 Sep;112(3 Pt 1):677-9. doi: 10.1542/peds.112.3.677. No abstract available.'}, {'pmid': '5067634', 'type': 'BACKGROUND', 'citation': 'Miller PH. Potential fire hazard in defibrillation. JAMA. 1972 Jul 10;221(2):192. No abstract available.'}, {'pmid': '9681318', 'type': 'BACKGROUND', 'citation': 'Cantello E, Davy TE, Koenig KL. The question of removing a ventilation bag before defibrillation. J Accid Emerg Med. 1998 Jul;15(4):286. doi: 10.1136/emj.15.4.286. No abstract available.'}, {'pmid': '11574364', 'type': 'BACKGROUND', 'citation': 'Barker SJ, Polson JS. Fire in the operating room: a case report and laboratory study. Anesth Analg. 2001 Oct;93(4):960-5. doi: 10.1097/00000539-200110000-00031.'}, {'pmid': '3184368', 'type': 'BACKGROUND', 'citation': 'Hummel RS 3rd, Ornato JP, Weinberg SM, Clarke AM. Spark-generating properties of electrode gels used during defibrillation. A potential fire hazard. JAMA. 1988 Nov 25;260(20):3021-4.'}]}, 'descriptionModule': {'briefSummary': 'European Resuscitation Council 2021 Guidelines and Advanced Life Support Provider Courses teach that the oxygen supply must be removed from the patient during defibrillation to the distance of minimum of 1 meter. Scientific articles describe few incidents of fire during defibrillation in oxygen - enriched atmospheres.\n\nThe study aims to performed a series of measurement of the oxygen concentration in the environment around the patient with different airway management used and ventilation provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients undergoing oxygen therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients at the intensive care unit bed or on the operating theatre with oxygen therapy prescribed/indicated\n\nExclusion Criteria:\n\n* no oxygen therapy started\n* situation not allowing measurement'}, 'identificationModule': {'nctId': 'NCT06718361', 'briefTitle': 'Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.'}, 'officialTitle': 'Assessing Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy: Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ZZSKVK-01-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'O2 mask', 'description': 'Delivering oxygen via face mask with different oxygen flow (5, 10, 15 l/min).', 'interventionNames': ['Other: Oxygen levels measurement (%)']}, {'label': 'Bag mask ventilation', 'description': 'Delivering oxygen via bag mask ventilation', 'interventionNames': ['Other: Oxygen levels measurement (%)']}, {'label': 'Supraglotic airway', 'description': 'Delivering oxygen via laryngeal mask with bag or mechanical ventilation', 'interventionNames': ['Other: Oxygen levels measurement (%)']}, {'label': 'Orotracheal intubation', 'description': 'Delivering oxygen via orotracheal tube with bag or mechanical ventilation', 'interventionNames': ['Other: Oxygen levels measurement (%)']}, {'label': 'High-Flow Nasal Oxygenation', 'description': 'Oxygen delivery via high-flow nasal oxygenation', 'interventionNames': ['Other: Oxygen levels measurement (%)']}], 'interventions': [{'name': 'Oxygen levels measurement (%)', 'type': 'OTHER', 'description': 'Measuring levels of oxygen in the environment around the patient in %.', 'armGroupLabels': ['Bag mask ventilation', 'High-Flow Nasal Oxygenation', 'O2 mask', 'Orotracheal intubation', 'Supraglotic airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'FNKV University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'David Peran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be part of the future publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Peran, PhD, FERC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charles University, Czech Republic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy director', 'investigatorFullName': 'David Peran, PhD, FERC', 'investigatorAffiliation': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.'}}}}