ClinicalTrials.gg
Status unknownNCT06064409Updated Oct 3, 2023

Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study

An observational study in Respiratory Insufficiency, Acute Hypercapnic Respiratory Failure and Acute Hypoxemic Respiratory Failure, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Respiratory Insufficiency
  • Acute Hypercapnic Respiratory Failure
  • Acute Hypoxemic Respiratory Failure
  • Hypercapnic Acute
  • Respiratory Failure
  • Hypercapnic Respiratory Failure
  • Hypoxemic Acute Respiratory Failure
  • Hypoxemic Respiratory Failure
  • Respiratory Depression
  • Ventilatory Depression
03

In context

Respiratory Insufficiency

1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 556 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

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

  • Patients with dyspnea and applied to HFNC in ED at Severance Hospital.

Exclusion criteria

Exclusion Criteria:

  • age\<18
  • GCS ≤ 12
  • Do not resuscitate patients, whom wishes not to included in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Endotracheal intubation

    Endotracheal intubation within 28 days of ED visit.

    Time frame: 28 days

Secondary outcomes

  1. Mortality

    Mortality within 28 days of ED visit.

    Time frame: 28 days

07

Study locations

1 site
  • Severance hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

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 Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06064409
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 3, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Mar 2025 (estimated)
Last update
Oct 3, 2023

Study contacts

Yongtak Cho
Contact
softweed@yuhs.ac
02-2228-2678
Yongtak Cho
principal investigator · epartment of Emergency Medicine, Yonsei university college of medicine

Oversight

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

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This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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