Utility of High Flow Nasal Cannula in CO Toxicity

April 8, 2018 updated by: Ibrahim Ulas Ozturan, Kocaeli University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Half life of COHb
Time Frame: 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.
between 20 and 120 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 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.
between 0 and 120 minutes
Device Comfort
Time Frame: 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".
Between 0 and 120 minutes
Flow Rate Tolerability
Time Frame: Between 0 and 120 minutes
Flow rate tolerability will be assessed according to patient request to change in flow rate.
Between 0 and 120 minutes
Flow Temperature Tolerability
Time Frame: Between 0 and 120 minutes.
Flow temperature tolerability will be assessed according to patient request to change in flow rate.
Between 0 and 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elif Yaka, Assoc. Prof., Kocaeli University
  • Principal Investigator: İbrahim U Özturan, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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