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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure
• Interventions: Device: Standard(symmetric) High flow nasal cannula; Device: Asymmetric High flow nasal cannula

• Registration Number: NCT06301035
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-03-03
• Study First Posted: 2024-03-08
• Status Verified: 2024-06
• Study Start: 2024-06-03
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard HFNC	Standard(symmetric) High flow nasal cannula	Standard HFNC
Asymmetric HFNC	Asymmetric High flow nasal cannula	Asymmetric HFNC

Primary Outcome Measures

Name	Time	Method
Respiratory Rate Oxygenation (ROX) Index	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	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

Secondary Outcome Measures

Name	Time	Method
The Lowest value of SpO2 within 24 hours after extubation	within 24 hours after extubation	Gas exchange (blood gas analysis) - The Lowest value of SpO2 within 24 hours after extubation
changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	Pulmonary Dynamics (EIT) - changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)
mean arterial pressure	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	hemodynamics - mean arterial pressure
ICU Mortality	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	clinical outcomes - ICU Mortality
28 Day Mortality	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	clinical outcomes - 28 Day Mortality
systolic blood pressure	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	hemodynamics - systolic blood pressure
Hospital Mortality	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	clinical outcomes - Hospital Mortality
PaO2/FiO2	30 minutes, 6 hours, 24 hours	Gas exchange (blood gas analysis) - PaO2/FiO2
SpO2/FiO2	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	Gas exchange (blood gas analysis) - SpO2/FiO2
Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	Pulmonary Dynamics (EIT) - Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)
Respiratory rate	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	respiratory capacity indicator - Respiratory rate
work of breath (Modified Borg Scale, MBS)	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	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
heart rate	1 hour, 2 hours, 6 hours, 12 hours, 24 hours	hemodynamics - heart rate
Rate of reintubation within 7 days	within 7 days after extubation	clinical outcomes - Rate of reintubation within 7 days
Length of ICU stay	From date of ICU admission until the date of ICU discharge, assessed up to 2 years	clinical outcomes - Length of ICU stay
90 Day Mortality	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	clinical outcomes - 90 Day Mortality
Length of hospital stay	From date of hospital admission until the date of hospital discharge, assessed up to 2 years	clinical outcomes - Length of hospital stay

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of