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

Primary Purpose

Carbon Monoxide Poisoning

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High-flow nasal cannula device
Non-rebreathing oxygen mask group
Sponsored by
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High-flow nasal cannula group

Non-rebreathing oxygen mask group

Arm Description

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

In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 24, 2019
Last Updated
February 4, 2019
Sponsor
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
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1. Study Identification

Unique Protocol Identification Number
NCT03818841
Brief Title
The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
Official Title
High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal cannula group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-rebreathing oxygen mask group
Arm Type
Other
Arm Description
In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula device
Other Intervention Name(s)
AIRVO 2, Fisher & Paykel Healthcare LTD
Intervention Description
Patients will be randomly allocated to this treatment
Intervention Type
Device
Intervention Name(s)
Non-rebreathing oxygen mask group
Other Intervention Name(s)
Standard non-rebreathing oxygen mask
Intervention Description
Patients will be randomly allocated to this treatment
Primary Outcome Measure Information:
Title
COHb reduction at 90 minutes
Description
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.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Variation in the incidence of delayed neurologic sequelae
Description
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.
Time Frame
6 weeks
Title
Variation in serum lactate concentration
Description
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.
Time Frame
6 weeks
Title
Variation in serum troponin concentration
Description
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.
Time Frame
6 weeks
Title
Variation in S100B levels concentration
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi M Castello, MD
Phone
+3903213733097
Email
luigi.castello@med.uniupo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Gavelli, MD
Email
francesco.gavelli@uniupo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi M Castello, MD
Organizational Affiliation
A.O.U. Maggiore della Carità di Novara
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi M Castello, MD
Phone
+3903213733097
Email
luigi.castello@med.uniupo.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25558703
Citation
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.
Results Reference
result
PubMed Identifier
29379952
Citation
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.
Results Reference
result
PubMed Identifier
27753502
Citation
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. Erratum In: Am J Respir Crit Care Med. 2017 Aug 1;196 (3):398-399.
Results Reference
result
PubMed Identifier
25866645
Citation
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.
Results Reference
result

Learn more about this trial

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

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