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

Not Applicable

• Conditions: Carbon Monoxide Poisoning
• Interventions: Device: Non-rebreathing oxygen mask group; Device: High-flow nasal cannula device

• Registration Number: NCT03818841
• Lead Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Status Verified: 2019-02
• Study Start: 2019-02-01
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-06
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-rebreathing oxygen mask group	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
High-flow nasal cannula group	High-flow nasal cannula device	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.; 🇮🇹 Novara, Italy