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Utility of High Flow Nasal Cannula in CO Toxicity

Primary Purpose

Carbon Monoxide Poisoning, Environmental Exposure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring carbon monoxide toxicity, high flow nasal cannula, emergency department

Eligibility Criteria

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

Inclusion Criteria:

  • The patients who are admitted to the emergency department with CO poisoning with a CoHB level of >10%.
  • The patients who accept to participate in the study.

Exclusion Criteria:

  • The patients who are <18 years old.
  • The patients who need mechanical ventilation
  • The patients who are implemented oxygen more than 30 minutes before the ED admission
  • The patients who will be transferred to the hyperbaric oxygen center before the CoHB levels are decreased to the half.

Sites / Locations

  • Kocaeli University Medical Faculty

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HFNC therapy

Arm Description

Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy will be implemented to CO-poisoned patients. Oxygen flow rate will be started 60 L/min and be decreased as the patient has requested.

Outcomes

Primary Outcome Measures

Half life of COHb
Half life of COHb levels (%) under the high flow nasal oxygen therapy. Elimination rate of COHb will be determined in every 10 minutes according to venous blood gas COHb level.

Secondary Outcome Measures

Adverse Events
Mucosal dryness, epistaxis and burn in the nasal cavity will be evaluated as a adverse events of high flow nasal cannula.
Device Comfort
Patient comfort will be assessed according to verbal numeric rating scale by asking to patient to say a number between 0 to 10 with 0 being "high flow nasal cannula can not be tolerated" and 10 being " the most comfortable breath ever".
Flow Rate Tolerability
Flow rate tolerability will be assessed according to patient request to change in flow rate.
Flow Temperature Tolerability
Flow temperature tolerability will be assessed according to patient request to change in flow rate.

Full Information

First Posted
October 28, 2017
Last Updated
April 8, 2018
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03342209
Brief Title
Utility of High Flow Nasal Cannula in CO Toxicity
Official Title
Determination of Half-life of the Carboxyhemoglobin Level and Utility of High Flow Nasal Cannula in Carbon Monoxide Toxicity in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.
Detailed Description
Carbon monoxide (CO) poisoning is common and potentially fatal environmental emergency which requires immediate attention. It is responsible for up to 40,000 emergency department (ED) visits and 5000 to 6000 deaths per year, making it one of the leading causes of poisoning death in the United States. The management options for CO poisoning are limited to high flow oxygen by face mask or hyperbaric oxygen treatment. While half-life of carboxyhemoglobin (COHb) in a patient treating with high flow oxygen via a nonbreathing face mask is 90 minutes, it becomes 30 minutes with hyperbaric oxygen treatment (HBO). The hypothesis of this study is using high flow nasal oxygen therapy in the CO poisoning may be more effective and safer treatment method comparing to standard oxygen therapy in the ED. Also, it may be a safe promising alternative of hyperbaric oxygen therapy. The aim of the study is to determine the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning, Environmental Exposure
Keywords
carbon monoxide toxicity, high flow nasal cannula, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC therapy
Arm Type
Experimental
Arm Description
Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy will be implemented to CO-poisoned patients. Oxygen flow rate will be started 60 L/min and be decreased as the patient has requested.
Intervention Type
Device
Intervention Name(s)
Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy
Intervention Description
A high flow nasal cannula will be implemented to the CO-poisoned patients. In the meantime, intravenous access and cardiac monitorization will have been establishing. When the high flow nasal cannula becomes ready, the first venous blood sample will be taken and the treatment will be started without any delay. The gas flow rate will be started at the rate of 30 liters per minute and will be increased to the max flow rate which patient can tolerate and FiO2 of 1.0. If the first COHb level is lesser than 10%, the patient will be excluded and will receive standard emergency care. The blood sample will be drawn from existing IV access every 10 minutes until the COHb levels become %50 or lesser of the initial level. Once the COHb level becomes 50% of initial measurement, following blood samples will be taken in every 30 minutes.
Primary Outcome Measure Information:
Title
Half life of COHb
Description
Half life of COHb levels (%) under the high flow nasal oxygen therapy. Elimination rate of COHb will be determined in every 10 minutes according to venous blood gas COHb level.
Time Frame
between 20 and 120 minutes
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Mucosal dryness, epistaxis and burn in the nasal cavity will be evaluated as a adverse events of high flow nasal cannula.
Time Frame
between 0 and 120 minutes
Title
Device Comfort
Description
Patient comfort will be assessed according to verbal numeric rating scale by asking to patient to say a number between 0 to 10 with 0 being "high flow nasal cannula can not be tolerated" and 10 being " the most comfortable breath ever".
Time Frame
Between 0 and 120 minutes
Title
Flow Rate Tolerability
Description
Flow rate tolerability will be assessed according to patient request to change in flow rate.
Time Frame
Between 0 and 120 minutes
Title
Flow Temperature Tolerability
Description
Flow temperature tolerability will be assessed according to patient request to change in flow rate.
Time Frame
Between 0 and 120 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients who are admitted to the emergency department with CO poisoning with a CoHB level of >10%. The patients who accept to participate in the study. Exclusion Criteria: The patients who are <18 years old. The patients who need mechanical ventilation The patients who are implemented oxygen more than 30 minutes before the ED admission The patients who will be transferred to the hyperbaric oxygen center before the CoHB levels are decreased to the half.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yaka, Assoc. Prof.
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
İbrahim U Özturan
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
State/Province
Izmit
ZIP/Postal Code
41300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Utility of High Flow Nasal Cannula in CO Toxicity

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