Carbon Monoxide PoisoningNCT06198595
Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications
An observational study of Carbon Monoxide Poisoning, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carbon Monoxide Poisoning
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who present to the emergency department with or are brought in due to CO intoxication will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent Şehir Hastanesi
Ankara, Çankaya, 06170
About this study
Official title: Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications: A Prospective, Observational Study
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.
Read the 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.
- Conditions
- Carbon Monoxide Poisoning
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normobaric oxygen therapy group | "Patients Receiving Oxygen from Hospital Circuits at Normal Atmospheric Pressure" | |
| Noninvasive mechanical ventilation group | "Patients Receiving High PEEP Oxygenation Without Advanced Airway via Mechanical Ventilation" | |
| EzPAP Positive Airway Pressure System | "Patients Receiving Positive Airway Pressure Support for Lung Expansion Without Advanced Airway via the EzPAP Device." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carboxyhemoglobin
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.
Measured: 6 hours later
lactate
Blood lactate levels are typically measured in millimoles per liter (mmol/L)
Measured: 6 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SAFA DÖNMEZ, MD, Principal investigator, ANKARA BİLKENT CİTY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198595
- Sponsor's protocol ID
- E2-23-5424
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. 2024 Apr;119(3):214-219. doi: 10.1007/s00063-023-01044-5. Epub 2023 Aug 2.
PubMed 37530814Kim 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.
PubMed 31706658Ozturan 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.
PubMed 30689450Turgut 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.
PubMed 33036847Roth 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.
PubMed 29866417Caglar 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.
PubMed 31637993Donmez S, Sener A, Isik NI, Gormeli Kurt N, Yenal K, Irem Mutlu R, Akbas I. Efficacy of different oxygen delivery methods in carbon monoxide poisoning: a prospective observational study. Inhal Toxicol. 2025 Aug-Sep;37(7-8):395-404. doi: 10.1080/08958378.2025.2580328. Epub 2025 Nov 6.
PubMed 41196897
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Treatments in Carbon Monoxide Intoxications: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06198595
- Acronym / sponsor ID
- E2-23-5424
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normobaric oxygen therapy group | – | –"Patients Receiving Oxygen from Hospital Circuits at Normal Atmospheric Pressure" |
| Noninvasive mechanical ventilation group | – | –"Patients Receiving High PEEP Oxygenation Without Advanced Airway via Mechanical Ventilation" |
| EzPAP Positive Airway Pressure System | – | –"Patients Receiving Positive Airway Pressure Support for Lung Expansion Without Advanced Airway via the EzPAP Device." |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who present to the emergency department with or are brought in due to CO intoxication will be included in the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
lactate
Time frame: 6 hours later
Blood lactate levels are typically measured in millimoles per liter (mmol/L)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 37530814Akkan 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.
- Background: PubMed 31706658Kim 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.
- Background: PubMed 30689450Ozturan 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.
- Background: PubMed 33036847Turgut 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.
- Background: PubMed 29866417Roth 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.
- Background: PubMed 31637993Caglar 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.
- Derived from this study: PubMed 41196897Donmez S, Sener A, Isik NI, Gormeli Kurt N, Yenal K, Irem Mutlu R, Akbas I. Efficacy of different oxygen delivery methods in carbon monoxide poisoning: a prospective observational study. Inhal Toxicol. 2025 Aug-Sep;37(7-8):395-404. doi: 10.1080/08958378.2025.2580328. Epub 2025 Nov 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAFA DÖNMEZ, MD principal investigator
ANKARA BİLKENT CİTY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carboxyhemoglobin (time frame: 6 hours later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198595, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.