Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-02 @ 5:48 AM
Study NCT ID:
NCT06198595
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carboxyhemoglobin', 'timeFrame': '6 hours later', 'description': 'Blood carboxyhemoglobin saturation is typically expressed as a percentage. For example, the statement "blood carboxyhemoglobin saturation is 5%" indicates that 5% of hemoglobin has been converted to carboxyhemoglobin. This ratio affects the oxygen-carrying capacity of the blood and serves as an indicator of carbon monoxide poisoning. After treatment, a decrease in this ratio signifies the elimination of carbon monoxide from the body and the restoration of normal oxygen-carrying function.'}, {'measure': 'lactate', 'timeFrame': '6 hours later', 'description': 'Blood lactate levels are typically measured in millimoles per liter (mmol/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbon Monoxide Poisoning']}, 'referencesModule': {'references': [{'pmid': '37530814', 'type': 'BACKGROUND', 'citation': 'Akkan S, Uyanik O. Comparing high-flow nasal oxygen therapy and normobaric oxygen therapy on the treatment of carbon monoxide poisoning. Med Klin Intensivmed Notfmed. 2024 Apr;119(3):214-219. doi: 10.1007/s00063-023-01044-5. Epub 2023 Aug 2.'}, {'pmid': '31706658', 'type': 'BACKGROUND', 'citation': 'Kim YM, Shin HJ, Choi DW, Kim JM, Lee SW, Jeong SH, Kim H. Comparison of high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy in carbon monoxide intoxication: A pilot study. Am J Emerg Med. 2020 Aug;38(8):1621-1626. doi: 10.1016/j.ajem.2019.158451. Epub 2019 Nov 6.'}, {'pmid': '30689450', 'type': 'BACKGROUND', 'citation': 'Ozturan IU, Yaka E, Suner S, Ozbek AE, Alyesil C, Dogan NO, Yilmaz S, Pekdemir M. Determination of carboxyhemoglobin half-life in patients with carbon monoxide toxicity treated with high flow nasal cannula oxygen therapy. Clin Toxicol (Phila). 2019 Jul;57(7):617-623. doi: 10.1080/15563650.2018.1540046. Epub 2019 Jan 28.'}, {'pmid': '33036847', 'type': 'BACKGROUND', 'citation': 'Turgut K, Yavuz E. CPAP versus HFNC use in carbon monoxide poisoning. Am J Emerg Med. 2021 Aug;46:727. doi: 10.1016/j.ajem.2020.09.085. Epub 2020 Oct 2. No abstract available.'}, {'pmid': '29866417', 'type': 'BACKGROUND', 'citation': 'Roth D, Mayer J, Schreiber W, Herkner H, Laggner AN. Acute carbon monoxide poisoning treatment by non-invasive CPAP-ventilation, and by reservoir face mask: Two simultaneous cases. Am J Emerg Med. 2018 Sep;36(9):1718.e5-1718.e6. doi: 10.1016/j.ajem.2018.05.066. Epub 2018 May 29.'}, {'pmid': '31637993', 'type': 'BACKGROUND', 'citation': 'Caglar B, Serin S, Yilmaz G, Torun A, Parlak I. The Impact of Treatment with Continuous Positive Airway Pressure on Acute Carbon Monoxide Poisoning. Prehosp Disaster Med. 2019 Dec;34(6):588-591. doi: 10.1017/S1049023X19005028. Epub 2019 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Carbon monoxide (CO) poisoning is a condition that occurs as a result of inhaling carbon monoxide gas and can potentially lead to serious health issues. The treatment of CO poisoning requires urgent medical intervention. Methods used in the treatment of CO poisoning include normobaric oxygen (oxygen at normal pressure), high-flow oxygen, non-invasive continuous positive airway pressure (CPAP), and hyperbaric oxygen therapy. Studies on these methods are available in the literature.', 'detailedDescription': "When examining the mechanisms of application for these methods:\n\nNormobaric Oxygen Therapy: In normobaric oxygen therapy, researchers treat participants with normobaric (sea level) oxygen. This method provides high concentrations of oxygen, allowing better oxygen saturation of the blood and faster removal of carbon monoxide from the body. Participants inhale normobaric oxygen through devices such as masks or nasal cannulas.\n\nHigh-Flow Oxygen Therapy: In high-flow oxygen therapy, researchers treat participants with high-flow oxygen. Typically, a nasal cannula or oxygen mask is used. The high flow rate allows more oxygen to reach the alveoli and bind to hemoglobin. This method can be effective, especially in more severe cases of carbon monoxide poisoning.\n\nNon-Invasive CPAP Therapy: Non-invasive CPAP therapy is typically used to treat respiratory problems such as sleep apnea but can also be used in the treatment of CO poisoning. Participants receive oxygen under continuous positive airway pressure with the help of a mask.\n\nComparison of these methods:\n\nNormobaric oxygen is considered the standard treatment for CO poisoning and generally effectively eliminates carbon monoxide from the body. High-flow oxygen may be more effective in providing additional oxygen in more severe cases, but it works similarly to normobaric oxygen. The choice of which treatment method to use can vary depending on the participant's clinical condition, the severity of poisoning, and other factors. The researchers main goal in designing this study is to determine which treatment, depending on the researcher's decision, most rapidly shortens the half-life of carbon monoxide in participants experiencing severe carbon monoxide poisoning.The researchers aim to identify which treatment participants tolerate better and which method minimizes complications related to CO intoxication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who present to the emergency department with or are brought in due to CO intoxication will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65,\n* Without any underlying health conditions,\n* Diagnosed with carbon monoxide poisoning,\n* Capable of providing consent either personally or through a legal representative.\n\nExclusion Criteria:\n\n* Under the age of 18,\n* Over the age of 65,\n* With underlying health conditions,\n* Without a diagnosis of carbon monoxide poisoning,\n* Patients who do not wish to share their data.'}, 'identificationModule': {'nctId': 'NCT06198595', 'briefTitle': 'Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications: A Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'E2-23-5424'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normobaric oxygen therapy group', 'description': '"Patients Receiving Oxygen from Hospital Circuits at Normal Atmospheric Pressure"'}, {'label': 'Noninvasive mechanical ventilation group', 'description': '"Patients Receiving High PEEP Oxygenation Without Advanced Airway via Mechanical Ventilation"'}, {'label': 'EzPAP Positive Airway Pressure System', 'description': '"Patients Receiving Positive Airway Pressure Support for Lung Expansion Without Advanced Airway via the EzPAP Device."'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent Şehir Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'SAFA DÖNMEZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ANKARA BİLKENT CİTY HOSPİTAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}