Carbon Monoxide Poisoning
Conditions
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.
Interventions
DEVICEHigh-flow nasal cannula device
Patients will be randomly allocated to this treatment
DEVICENon-rebreathing oxygen mask group
Patients will be randomly allocated to this treatment
Sponsors
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COHb reduction at 90 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in the incidence of delayed neurologic sequelae | 6 weeks | 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. |
| Variation in serum lactate concentration | 6 weeks | 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. |
| Variation in serum troponin concentration | 6 weeks | 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. |
| Variation in S100B levels concentration | 6 weeks | 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. |
Countries
Italy
Contacts
Primary ContactLuigi M Castello, MD
Backup ContactFrancesco Gavelli, MD
Outcome results
None listed