Utility of High Flow Nasal Cannula in CO Toxicity

Determination of Half-life of the Carboxyhemoglobin Level and Utility of High Flow Nasal Cannula in Carbon Monoxide Toxicity in the Emergency Department

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

Study Overview

• Status: Completed
• Conditions: Environmental Exposure; Carbon Monoxide Poisoning
• Intervention / Treatment: Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmit
    • Kocaeli, Izmit, Turkey, 41300
      • Kocaeli University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between 20 and 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Mucosal dryness, epistaxis and burn in the nasal cavity will be evaluated as a adverse events of high flow nasal cannula.	between 0 and 120 minutes
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".	Between 0 and 120 minutes
Flow Rate Tolerability	Flow rate tolerability will be assessed according to patient request to change in flow rate.	Between 0 and 120 minutes
Flow Temperature Tolerability	Flow temperature tolerability will be assessed according to patient request to change in flow rate.	Between 0 and 120 minutes.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: October 28, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 8, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: emergency department; high flow nasal cannula; carbon monoxide toxicity
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: KIA 2016/286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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