The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Clinical Trial

Official title:

High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818841
• Other study ID #: CO-HFNC
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2019
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: Luigi M Castello, MD
• Phone: +3903213733097
• Email: luigi.castello[@]med.uniupo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age v 18 years

• Carbon monoxide intoxication as major problem leading to emergency department admission

• Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment

Exclusion Criteria:

• Age < 18 years

• Glasgow coma scale = 13

• Refusal to give consent

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Device:
• High-flow nasal cannula device
Patients will be randomly allocated to this treatment
• Non-rebreathing oxygen mask group
Patients will be randomly allocated to this treatment

Locations

Country	Name	City	State
Italy	AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. Errat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	6 weeks
Secondary	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
Secondary	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
Secondary	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