Respiratory InsufficiencyNCT06064409
Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
An observational study of Respiratory Insufficiency and Acute Hypercapnic Respiratory Failure, run by Yonsei University at 1 site in South Korea.
Trial summary
This study targets adult patients treated with high flow nasal cannula (HFNC) at emergency department (ED) of Severance hospital, Yonsei university. Patients with acute hypoxic respiratory failure presenting to the ED receive conventional oxygen therapy as initial treatment unless immediate endotracheal intubation is… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Insufficiency, Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2023to Mar 2025
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Respiratory rate more than 20 breaths per minute 2. PF ratio<300mmHg despite conventional oxygen therapy 3. HFNC is needed clinically, such as the use of auxiliary respiratory muscles
Who may be able to join
- Patients with dyspnea and applied to HFNC in ED at Severance Hospital.
Who cannot join
- age<18
- GCS ≤ 12
- Do not resuscitate patients, whom wishes not to included in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance hospital
Seoul
Yongtak Cho, 02-2228-2678, softweed@yuhs.ac
About this study
This study targets adult patients treated with high flow nasal cannula (HFNC) at emergency department (ED) of Severance hospital, Yonsei university. Patients with acute hypoxic respiratory failure presenting to the ED receive conventional oxygen therapy as initial treatment unless immediate endotracheal intubation is required. Partial rebreathing oxygen masks are mainly applied at first. If the patient's condition does not improve despite such treatment, the patient receives HFNC or endotracheal intubation. However, possible treatment range have not been studied, especially in ED. Decisions are made based on the personal experience of the medical staff in charge. Applying HFNC to patients who eventually fail can lead to delayed intubation and increased mortality. Failure prediction models such as ROX index and HACOR score have been developed due to such reasons. However, such models are mostly based on intensive care unit studies and after application of HFNC. Therefore, failure prediction model at the time before application of HFNC and efficacy of existing models in ED are necessary.
This study is a prospective observational study and follows the standard treatment guidelines applied to the patient and the judgment of the attending physician during the patient's treatment process. Immediately before applying HFNC, the patient's respiratory rate, pulse rate, blood pressure, SpO₂, PaO₂, PaCO₂, GCS score are determined, and FiO₂ is measured above upper lips using oxygen analyzer(MaxO2+AE, Maxtec, USA). From these data, ROX index (SF ratio/respiratory rate), ROX-HR (ROX index/pulse rate), POX index (PF ratio/respiratory rate), POX-HR (POX index/pulse rate), and HACOR score (Heart Rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) are calculated. The settings (flow rate, FiO₂, temperature) at the time of HFNC application are also measured. The same indices and HFNC settings are checked 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours after applying HFNC. Modified Borg score and comfort scale using 5-point Likert scale are additionally determined at 30 minutes for patient's comfort. Primary outcome is HFNC failure at 28 days, defined by endotracheal intubation. Other outcomes include intubation in ED and mortality at 28 and 90 days collected through phone interview.
The receiver operating curve for ROX index, HACOR score, ROX-HR, and POX-HR at baseline, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours are drawn for the outcomes. The area under the curve of the above indices are compared and cutoff values are chosen with maximum value of index J by the Youden's Index. A binary variable is created based on the cutoff values and multivariable logistic regression analyses are performed. Cutoff values for maximum specificity are also invested suggesting the lower limit of the indicator to which HFNC can be applied.
- Conditions
- Respiratory Insufficiency, Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure, Hypercapnic Acute, Respiratory Failure, Hypercapnic Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute hypoxemic respiratory failure group | Patients with hypoxemic respiratory failure, defined as decreased PaO2. | |
| Acute hypercapneic respiratory failure group | Patients with hypercapneic respiratory failure, defined as increased PaCO2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation
Endotracheal intubation within 28 days of ED visit.
Measured: 28 days
Secondary outcomes (1)
Mortality
Mortality within 28 days of ED visit.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongtak Cho, Principal investigator, epartment of Emergency Medicine, Yonsei university college of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064409
- Sponsor's protocol ID
- 4-2023-0734
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
- ClinicalTrials.gov ID
- NCT06064409
- Acronym / sponsor ID
- 4-2023-0734
- Conditions
- Respiratory Insufficiency, Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure, Hypercapnic Acute, Respiratory Failure, Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 3 Oct 2023 (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.
This study targets adult patients treated with high flow nasal cannula (HFNC) at emergency department (ED) of Severance hospital, Yonsei university. Patients with acute hypoxic respiratory failure presenting to the ED receive conventional oxygen therapy as initial treatment unless immediate endotracheal intubation is required. Partial rebreathing oxygen masks are mainly applied at first. If the patient's condition does not improve despite such treatment, the patient receives HFNC or endotracheal intubation. However, possible treatment range have not been studied, especially in ED. Decisions are made based on the personal experience of the medical staff in charge. Applying HFNC to patients who eventually fail can lead to delayed intubation and increased mortality. Failure prediction models such as ROX index and HACOR score have been developed due to such reasons. However, such models are mostly based on intensive care unit studies and after application of HFNC. Therefore, failure prediction model at the time before application of HFNC and efficacy of existing models in ED are necessary.
This study is a prospective observational study and follows the standard treatment guidelines applied to the patient and the judgment of the attending physician during the patient's treatment process. Immediately before applying HFNC, the patient's respiratory rate, pulse rate, blood pressure, SpO₂, PaO₂, PaCO₂, GCS score are determined, and FiO₂ is measured above upper lips using oxygen analyzer(MaxO2+AE, Maxtec, USA). From these data, ROX index (SF ratio/respiratory rate), ROX-HR (ROX index/pulse rate), POX index (PF ratio/respiratory rate), POX-HR (POX index/pulse rate), and HACOR score (Heart Rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) are calculated. The settings (flow rate, FiO₂, temperature) at the time of HFNC application are also measured. The same indices and HFNC settings are checked 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours after applying HFNC. Modified Borg score and comfort scale using 5-point Likert scale are additionally determined at 30 minutes for patient's comfort. Primary outcome is HFNC failure at 28 days, defined by endotracheal intubation. Other outcomes include intubation in ED and mortality at 28 and 90 days collected through phone interview.
The receiver operating curve for ROX index, HACOR score, ROX-HR, and POX-HR at baseline, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours are drawn for the outcomes. The area under the curve of the above indices are compared and cutoff values are chosen with maximum value of index J by the Youden's Index. A binary variable is created based on the cutoff values and multivariable logistic regression analyses are performed. Cutoff values for maximum specificity are also invested suggesting the lower limit of the indicator to which HFNC can be applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute hypoxemic respiratory failure group | – | –Patients with hypoxemic respiratory failure, defined as decreased PaO2. |
| Acute hypercapneic respiratory failure group | – | –Patients with hypercapneic respiratory failure, defined as increased PaCO2. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Respiratory rate more than 20 breaths per minute 2. PF ratio<300mmHg despite conventional oxygen therapy 3. HFNC is needed clinically, such as the use of auxiliary respiratory muscles
Key inclusion criteria (1 listed)
- Patients with dyspnea and applied to HFNC in ED at Severance Hospital.
Key exclusion criteria (3 listed)
- age<18
- GCS ≤ 12
- Do not resuscitate patients, whom wishes not to included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endotracheal intubation
Time frame: 28 days
Endotracheal intubation within 28 days of ED visit.
1 secondary outcome
Mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Yongtak Cho principal investigator
epartment of Emergency Medicine, Yonsei university college of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Acute Hypercapnic Respiratory Failure, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongtak Cho (02-2228-2678, softweed@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation (time frame: 28 days). 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 3 Oct 2023.