Carbon Monoxide PoisoningNCT03818841
The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
A study testing High-flow nasal cannula device and Non-rebreathing oxygen mask group in people with Carbon Monoxide Poisoning, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- High-flow nasal cannula device and Non-rebreathing oxygen mask group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age v 18 years
- Carbon monoxide intoxication as major problem leading to emergency department admission
- Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment
Who cannot join
- Age < 18 years
- Glasgow coma scale ≤ 13
- Refusal to give consent
Trial locations and contacts
1 site in 1 country.
Francesco Gavelli, MD contact
Italy1 site, 1 recruiting
- Recruiting
AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.
Novara, 28100
Luigi M Castello, MD, +3903213733097, luigi.castello@med.uniupo.it
About this study
Official title: 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.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- High-flow nasal cannula device, Non-rebreathing oxygen mask group
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula deviceDevice
Also called AIRVO 2, Fisher & Paykel Healthcare LTD
Patients will be randomly allocated to this treatment
Non-rebreathing oxygen mask groupDevice
Also called Standard non-rebreathing oxygen mask
Patients will be randomly allocated to this treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Non-rebreathing oxygen mask group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi M Castello, MD, Principal investigator, A.O.U. Maggiore della Carità di Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818841
- Sponsor's protocol ID
- CO-HFNC
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25558703Jeon 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.
PubMed 29379952Rose 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.
PubMed 27753502Nishimura 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.
PubMed 25866645
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT03818841
- Acronym / sponsor ID
- CO-HFNC
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula group | Experimental | Device: High-flow nasal cannula devicePatients 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 |
| Non-rebreathing oxygen mask group | Other | Device: Non-rebreathing oxygen mask groupIn this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age v 18 years
- Carbon monoxide intoxication as major problem leading to emergency department admission
- Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment
Key exclusion criteria (3 listed)
- Age < 18 years
- Glasgow coma scale ≤ 13
- Refusal to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal cannula deviceAlso: AIRVO 2, Fisher & Paykel Healthcare LTDPatients will be randomly allocated to this treatment | Device | High-flow nasal cannula group |
| Non-rebreathing oxygen mask groupAlso: Standard non-rebreathing oxygen maskPatients will be randomly allocated to this treatment | Device | Non-rebreathing oxygen mask group |
Primary outcome
COHb reduction at 90 minutes
Time frame: 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.
4 secondary outcomes
Variation in the incidence of delayed neurologic sequelae
Time frame: 6 weeks
Variation in serum lactate concentration
Time frame: 6 weeks
Variation in serum troponin concentration
Time frame: 6 weeks
Variation in S100B levels concentration
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Results publication: PubMed 25558703Brotfain 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.
- Results publication: PubMed 29379952Jeon 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.
- Results publication: PubMed 27753502Rose 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.
- Results publication: PubMed 25866645Nishimura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Gavelli, MD contact
Luigi M Castello, MD principal investigator
A.O.U. Maggiore della Carità di Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula device and Non-rebreathing oxygen mask group in people with Carbon Monoxide Poisoning, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi M Castello, MD (+3903213733097, luigi.castello@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COHb reduction at 90 minutes (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.