Carbon Monoxide PoisoningNCT03342209
Utility of High Flow Nasal Cannula in CO Toxicity
A study testing Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy in people with Carbon Monoxide Poisoning and Environmental Exposure, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning, Environmental Exposure
- What is being tested?
- Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 6 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Medical Faculty
Kocaeli, Izmit, 41300
About this study
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
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.
- Conditions
- Carbon Monoxide Poisoning, Environmental Exposure
- Being tested
- Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy
- Keywords
- carbon monoxide toxicity, high flow nasal cannula, emergency department
- Medical subject headings
- Carbon Monoxide Poisoning, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HFNC therapy | Experimental | 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. Receives: Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 20 and 120 minutes
Secondary outcomes (4)
Adverse Events
Mucosal dryness, epistaxis and burn in the nasal cavity will be evaluated as a adverse events of high flow nasal cannula.
Measured: 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".
Measured: Between 0 and 120 minutes
Flow Rate Tolerability
Flow rate tolerability will be assessed according to patient request to change in flow rate.
Measured: Between 0 and 120 minutes
Flow Temperature Tolerability
Flow temperature tolerability will be assessed according to patient request to change in flow rate.
Measured: Between 0 and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Mar 2017
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ulas Ozturan, Kocaeli University
- Investigators
- Elif Yaka, Assoc. Prof., Study chair, Kocaeli Universityİbrahim U Özturan, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342209
- Sponsor's protocol ID
- KIA 2016/286
- Status last verified
- Nov 2017
- First submitted
- 28 Oct 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03342209
- Acronym / sponsor ID
- KIA 2016/286
- Conditions
- Carbon Monoxide Poisoning, Environmental Exposure
- Keywords
- carbon monoxide toxicity, high flow nasal cannula, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNC therapy | Experimental | Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula TherapyFisher\&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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula TherapyA 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. | Device | HFNC therapy |
Primary outcome
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.
4 secondary outcomes
Adverse Events
Time frame: between 0 and 120 minutes
Device Comfort
Time frame: Between 0 and 120 minutes
Flow Rate Tolerability
Time frame: Between 0 and 120 minutes
Flow Temperature Tolerability
Time frame: Between 0 and 120 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yaka, Assoc. Prof. study chair
Kocaeli University
İbrahim U Özturan principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy in people with Carbon Monoxide Poisoning and Environmental Exposure, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half life of COHb (time frame: between 20 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.