NCT03818841

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

January 24, 2019

Last Update Submit

February 4, 2019

Conditions

Carbon Monoxide Poisoning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Variation in the incidence of delayed neurologic sequelae

    6 weeks

  • Variation in serum lactate concentration

    6 weeks

  • Variation in serum troponin concentration

    6 weeks

  • Variation in S100B levels concentration

    6 weeks

Study Arms (2)

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

Device: High-flow nasal cannula device

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

Device: Non-rebreathing oxygen mask group

Interventions

High-flow nasal cannula deviceDEVICE

Patients will be randomly allocated to this treatment

Also known as: AIRVO 2, Fisher & Paykel Healthcare LTD
High-flow nasal cannula group
Non-rebreathing oxygen mask groupDEVICE

Patients will be randomly allocated to this treatment

Also known as: Standard non-rebreathing oxygen mask
Non-rebreathing oxygen mask group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age v 18 years
  • Carbon monoxide intoxication as major problem leading to emergency department admission
  • Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment

You may not qualify if:

  • Age \< 18 years
  • Glasgow coma scale ≤ 13
  • Refusal to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Novara, 28100, Italy

RECRUITING

Related 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. 2014 Nov;16(11):718-22.

    PMID: 25558703RESULT

  • 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.

    PMID: 29379952RESULT

  • 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.

    PMID: 27753502RESULT

  • 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.

    PMID: 25866645RESULT

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Luigi M Castello, MD

    A.O.U. Maggiore della Carità di Novara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi M Castello, MD

CONTACT

+3903213733097luigi.castello@med.uniupo.it

Francesco Gavelli, MD

CONTACT

francesco.gavelli@uniupo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

February 1, 2019

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)