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

Samsung Medical Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Asymmetric High flow nasal cannulaDEVICE

* 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(symmetric) High flow nasal cannulaDEVICE

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Respiratory Rate Oxygenation (ROX) Index

Changes in Respiratory Rate Oxygenation (ROX) Index after extubation 4.88 ≤ ROX index ; Low Risk 3.85 ≤ ROX index \< 4.88 ; Re-evaluate after 1-2 hours 3.85 \> ROX index ; considerate about intubation

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Secondary Outcomes

The Lowest value of SpO2 within 24 hours after extubation

Gas exchange (blood gas analysis) - The Lowest value of SpO2 within 24 hours after extubation

Time frame: within 24 hours after extubation

PaO2/FiO2

Gas exchange (blood gas analysis) - PaO2/FiO2

Time frame: 30 minutes, 6 hours, 24 hours

SpO2/FiO2

Gas exchange (blood gas analysis) - SpO2/FiO2

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)

Pulmonary Dynamics (EIT) - changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)

Pulmonary Dynamics (EIT) - Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Respiratory rate

respiratory capacity indicator - Respiratory rate

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

work of breath (Modified Borg Scale, MBS)

respiratory capacity indicator - work of breath (Modified Borg Scale, MBS) :The degree of work of breath is indicated by the patient himself/herself 0: Nothing at all 0.5: Very, very slight (just noticeable) 1. Very slight 2. Slight 3. Moderate 4. Somewhat severe 5,: Severe 6, 7: Very severe 8, 9: Very, very severe (almost maximal) 10: Maximal

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

systolic blood pressure

hemodynamics - systolic blood pressure

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

mean arterial pressure

hemodynamics - mean arterial pressure

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

heart rate

hemodynamics - heart rate

Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Rate of reintubation within 7 days

clinical outcomes - Rate of reintubation within 7 days

Time frame: within 7 days after extubation

Length of ICU stay

clinical outcomes - Length of ICU stay

Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 2 years

Length of hospital stay

clinical outcomes - Length of hospital stay

Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 2 years

ICU Mortality

clinical outcomes - ICU Mortality

Time frame: From date of extubation until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 1 year

Hospital Mortality

clinical outcomes - Hospital Mortality

Time frame: From date of extubation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year

28 Day Mortality

clinical outcomes - 28 Day Mortality

Time frame: From date of extubation until the date of 28 Day or date of death from any cause, whichever came first, assessed up to 1 months

90 Day Mortality

clinical outcomes - 90 Day Mortality

Time frame: From date of extubation until the date of 90 Day or date of death from any cause, whichever came first, assessed up to 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes