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CompletedNCT03342209Updated Apr 10, 2018

Utility of High Flow Nasal Cannula in CO Toxicity

An interventional study of Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy in Carbon Monoxide Poisoning and Environmental Exposure, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Kocaeli University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Carbon Monoxide Poisoning
  • Environmental Exposure

Keywords

  • carbon monoxide toxicity
  • high flow nasal cannula
  • emergency department
03

In context

Carbon Monoxide Poisoning

44 studies on the registry are indexed under Carbon Monoxide Poisoning; 8 are open to participants now.

This study's enrollment of 35 is below the median of 74 across 16 interventional studies indexed under Carbon Monoxide Poisoning.

Browse Carbon Monoxide Poisoning studies →

Lead sponsor

Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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

Interventions

  • DeviceFisher&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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: between 20 and 120 minutes

Secondary outcomes

  1. Adverse Events

    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

  2. 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".

    Time frame: Between 0 and 120 minutes

  3. Flow Rate Tolerability

    Flow rate tolerability will be assessed according to patient request to change in flow rate.

    Time frame: Between 0 and 120 minutes

  4. Flow Temperature Tolerability

    Flow temperature tolerability will be assessed according to patient request to change in flow rate.

    Time frame: Between 0 and 120 minutes.

07

Study locations

1 site
  • Kocaeli University Medical Faculty
    Kocaeli, Izmit 41300, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03342209
Lead sponsor
Kocaeli University
Responsible party
Ibrahim Ulas Ozturan (Principle Investigator, MD, Kocaeli University) — Principal investigator
First posted
Nov 14, 2017
Start date
Mar 1, 2017
Primary completion
Feb 6, 2018
Completion
Feb 6, 2018
Last update
Apr 10, 2018

Study contacts

Elif Yaka, Assoc. Prof.
study chair · Kocaeli University
İbrahim U Özturan
principal investigator · Kocaeli University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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