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The aim of the study is to test whether oxygen therapy delivered through high-flow nasal cannula devices in patients admitted to the emergency department for acute carbon monoxide poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin (COHb) concentration and delayed neurological sequelae incidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula group | Experimental | Patients randomised in this group will receive oxygen therapy via a high-flow nasal cannula device with a 60 L/min flow and a 100% fraction of inspired oxygen |
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| Non-rebreathing oxygen mask group | Other | In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula device | Device | Patients will be randomly allocated to this treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| COHb reduction at 90 minutes | Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of COHb reduction at 90 minutes. The hypothesis is that in patients treated with high flow nasal cannula the reduction in COHb at 90 minutes will be significantly different compared to patients treated with non-rebreathing oxygen mask. | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in the incidence of delayed neurologic sequelae | Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of incidence and severity of delayed neurologic syndrome. At the time of discharge from the emergency department, each enrolled patient will undergo neurocognitive testing. Six weeks after discharge, a follow-up visit for each patient will be performed which will include neurocognitive testing and a functional magnetic resonance imaging, in order to determine the presence of delayed neurologic sequelae. Patients in the two groups of treatment will be subsequently compared. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi M Castello, MD | Contact | +3903213733097 | luigi.castello@med.uniupo.it | |
| Francesco Gavelli, MD | Contact | francesco.gavelli@uniupo.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi M Castello, MD | A.O.U. Maggiore della Carità di Novara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine. | Recruiting | Novara | 28100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25558703 | Result | Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22. | |
| 29379952 | Result | Jeon SB, Sohn CH, Seo DW, Oh BJ, Lim KS, Kang DW, Kim WY. Acute Brain Lesions on Magnetic Resonance Imaging and Delayed Neurological Sequelae in Carbon Monoxide Poisoning. JAMA Neurol. 2018 Apr 1;75(4):436-443. doi: 10.1001/jamaneurol.2017.4618. |
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| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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Randomised controlled trial
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| Non-rebreathing oxygen mask group | Device | Patients will be randomly allocated to this treatment |
|
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| 6 weeks |
| Variation in serum lactate concentration | Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum lactate variations. In particular, serum lactate levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic. | 6 weeks |
| Variation in serum troponin concentration | Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of troponin concentration variations. In particular, serum troponin levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic. | 6 weeks |
| Variation in S100B levels concentration | Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum protein S100B variations. In particular, protein S100B will be evaluated at different time points, in order to test whether different treatments lead to different protein kinetic. | 6 weeks |
| 27753502 | Result | Rose JJ, Wang L, Xu Q, McTiernan CF, Shiva S, Tejero J, Gladwin MT. Carbon Monoxide Poisoning: Pathogenesis, Management, and Future Directions of Therapy. Am J Respir Crit Care Med. 2017 Mar 1;195(5):596-606. doi: 10.1164/rccm.201606-1275CI. |
| 25866645 | Result | Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015. |