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

NCT ID: NCT03818841

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carbon Monoxide Poisoning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

High-flow nasal cannula device

Intervention Type DEVICE

Patients will be randomly allocated to this treatment

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

Group Type OTHER

Non-rebreathing oxygen mask group

Intervention Type DEVICE

Patients will be randomly allocated to this treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-flow nasal cannula device

Patients will be randomly allocated to this treatment

Intervention Type DEVICE

Non-rebreathing oxygen mask group

Patients will be randomly allocated to this treatment

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AIRVO 2, Fisher & Paykel Healthcare LTD Standard non-rebreathing oxygen mask

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luigi M Castello, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Maggiore della Carità di Novara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.

Novara, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luigi M Castello, MD

Role: CONTACT

+3903213733097

Francesco Gavelli, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luigi M Castello, MD

Role: primary

+3903213733097

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25558703 (View on PubMed)

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.

Reference Type RESULT
PMID: 29379952 (View on PubMed)

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.

Reference Type RESULT
PMID: 27753502 (View on PubMed)

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.

Reference Type RESULT
PMID: 25866645 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CO-HFNC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HFNT vs. COT in COVID-19
NCT04655638 COMPLETED NA