Skip to main content
OpenTrials
Completed

NCT Number: NCT03342209

Utility of High Flow Nasal Cannula in CO Toxicity

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carbon Monoxide Poisoning Chemically-Induced Disorders Disease Attributes Emergencies Environmental Exposure Gas Poisoning Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Medical Faculty

Kocaeli, Izmit, 41300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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".

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2017
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.