- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198595
Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications
Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications: A Prospective, Observational Study
Study Overview
Status
Conditions
Detailed Description
When examining the mechanisms of application for these methods:
Normobaric 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.
High-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.
Non-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.
Comparison of these methods:
Normobaric 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: SAFA DÖNMEZ, MD
- Phone Number: +90 553 751 55 45
- Email: drsafa0131@gmail.com
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey, 06170
- Recruiting
- Ankara Bilkent Sehir Hastanesi
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Contact:
- Safa Dönmez, M.D.
- Email: drsafa0131@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages of 18 and 65,
- Without any underlying health conditions,
- Diagnosed with carbon monoxide poisoning,
- Capable of providing consent either personally or through a legal representative.
Exclusion Criteria:
- Under the age of 18,
- Over the age of 65,
- With underlying health conditions,
- Without a diagnosis of carbon monoxide poisoning,
- Patients who do not wish to share their data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Normobaric oxygen therapy group
"Patients Receiving Oxygen from Hospital Circuits at Normal Atmospheric Pressure"
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Hyperbaric oxygen therapy group
"Patients Receiving High-Pressure Oxygen at Pressures Above Atmospheric Pressure"
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Noninvasive mechanical ventilation group
"Patients Receiving High PEEP Oxygenation Without Advanced Airway via Mechanical Ventilation"
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High-flow oxygen therapy group
"Patients Reaching High FiO2 Levels Noninvasively Through High-Flow Oxygen Therapy"
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carboxyhemoglobin
Time Frame: 6 hours later
|
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.
|
6 hours later
|
lactate
Time Frame: 6 hours later
|
Blood lactate levels are typically measured in millimoles per liter (mmol/L)
|
6 hours later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SAFA DÖNMEZ, MD, Ankara Bilkent City Hospital
Publications and helpful links
General Publications
- 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. 2023 Aug 2. doi: 10.1007/s00063-023-01044-5. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-23-5424
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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