Utility of High Flow Nasal Cannula in CO Toxicity

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT03342209

Collaborator

(none)

Enrollment

Location

Arm

11.2

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Condition or Disease	Intervention/Treatment	Phase
Carbon Monoxide Poisoning Environmental Exposure	Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Feb 6, 2018

Actual Study Completion Date :

Feb 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HFNC therapy 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.	Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy 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.

Arm

Intervention/Treatment

Experimental: HFNC therapy

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.

Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy

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.

Outcome Measures

Primary Outcome Measures

Half life of COHb [between 20 and 120 minutes]
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 [between 0 and 120 minutes]
Mucosal dryness, epistaxis and burn in the nasal cavity will be evaluated as a adverse events of high flow nasal cannula.
Device Comfort [Between 0 and 120 minutes]
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 [Between 0 and 120 minutes]
Flow rate tolerability will be assessed according to patient request to change in flow rate.
Flow Temperature Tolerability [Between 0 and 120 minutes.]
Flow temperature tolerability will be assessed according to patient request to change in flow rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University Medical Faculty	Kocaeli	Izmit	Turkey	41300

Sponsors and Collaborators

Kocaeli University

Investigators

Study Chair: Elif Yaka, Assoc. Prof., Kocaeli University
Principal Investigator: İbrahim U Özturan, Kocaeli University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ibrahim Ulas Ozturan, Principle Investigator, MD, Kocaeli University

ClinicalTrials.gov Identifier:

NCT03342209

Other Study ID Numbers:

KIA 2016/286

First Posted:

Nov 14, 2017

Last Update Posted:

Apr 10, 2018

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ibrahim Ulas Ozturan, Principle Investigator, MD, Kocaeli University

carbon monoxide toxicity

high flow nasal cannula

emergency department

Additional relevant MeSH terms:

Poisoning

Carbon Monoxide Poisoning

Study Results

No Results Posted as of Apr 10, 2018