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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Device: High-flow nasal cannula device; Device: Non-rebreathing oxygen mask group

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luigi M Castello, MD; Phone Number: +3903213733097; Email: luigi.castello@med.uniupo.it
• Study Contact Backup: Name: Francesco Gavelli, MD; Email: francesco.gavelli@uniupo.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.
    • Contact: Luigi M Castello, MD; Phone Number: +3903213733097; Email: luigi.castello@med.uniupo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flow nasal cannula group; 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	Device: High-flow nasal cannula device; Patients will be randomly allocated to this treatment; Other Names: AIRVO 2, Fisher & Paykel Healthcare LTD
Other: Non-rebreathing oxygen mask group; In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow	Device: Non-rebreathing oxygen mask group; Patients will be randomly allocated to this treatment; Other Names: Standard non-rebreathing oxygen mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Investigators: Principal Investigator: Luigi M Castello, MD, A.O.U. Maggiore della Carità di Novara

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Am J Respir Crit Care Med. 2017 Aug 1;196 (3):398-399.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: CO-HFNC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No