Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2025-07-15

Brief Summary

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Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.

Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.

Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.

Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure.

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Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Asymmetric HFNC

Group Type EXPERIMENTAL

Asymmetric High flow nasal cannula

Intervention Type DEVICE

* Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
* The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
* After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Standard HFNC

Group Type ACTIVE_COMPARATOR

Standard(symmetric) High flow nasal cannula

Intervention Type DEVICE

* Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
* The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
* After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Interventions

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Asymmetric High flow nasal cannula

* Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
* The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
* After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Intervention Type DEVICE

Standard(symmetric) High flow nasal cannula

* Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
* The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
* After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 19 years of age or older
2. Patients who applied mechanical ventilation treatment for more than 24 hours before the excision
3. Patients who underwent endotracheal intubation rather than tracheal incision
4. Planned extubation after successful spontaneous breathing trial (SBT)
5. Reintubation High Risk Patients: If any of the following conditions are met

1. Age \> 65
2. Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation \> 12
3. Body mass index (BMI) \> 30 kg/m2
4. Inability to deal with respiratory secretions

* improper cough reflex
* If at least three aspirations are required in the 8 hours prior to the discharge
5. Difficult or long delay in mechanical ventilation

* The first attempt to leave the mechanical ventilation failed
6. Charlson Commercial Index (CCI) at least 2 categories of comorbidities
7. Heart failure is the main indication of mechanical ventilation application
8. Moderate to severe chronic obstructive pulmonary disease
9. If there is a problem with airway openness (high risk of developing laryngeal edema)

* a woman
* Oral endotracheal intubation maintenance period of at least 3 days
* Difficult to intubate endotracheally (difficult airway)
10. Long-term mechanical ventilation application: When applied for more than 7 days

Exclusion Criteria

1. a patient with a tracheostomy tube
2. Contraindicated application of nasal interfaces

* a nasal disorder
3. Continuous positive pressure (CPAP) application contraindications

* pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc
4. EIT application contraindications

* Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators)
* a patient with hyperhidrosis
* a patient whose physical movements are not controlled
* a pregnant woman
* BMI 50 or higher

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No