The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.

Detailed Description
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There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure. These review all have similar results summarized here: Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation. However, most of these clinical trials focused on participants experiencing acute respiratory failure. Investigators of this study want to find something difference between oh these two groups.

Official Title
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The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center

Conditions
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Critically Illness

Intervention / Treatment
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* Device: Heated Humidified High-Flow Nasal Cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: Over 20 years of age the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days Exclusion Criteria: Pregnancy Status post tracheostomy Neuromuscular diseases Signed do not resuscitate order Unplanned extubation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive Ventilation group<br>Noninvasive Ventilation group initial setting： Insp. Pressure：12   16 centimeter of water Exp. Pressure ： 4   6 centimeter of water FiO2：Keep oxygen saturation measured by pulse oximeter：> 92% By condition, gradually tap 2 3 centimeter of water inspiratory positive airway pressure Keep Tidal volume：6 10 ml/kg | Device: Heated Humidified High-Flow Nasal Cannula<br>* Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.<br>* Other names: Noninvasive Ventilation;|
| Active Comparator: Heated Humidified High-Flow Nasal Cannula group<br>Heated Humidified High-Flow Nasal Cannula group initial setting： Flow setting: 50 L/m FiO2：Keep oxygen saturation measured by pulse oximeter > 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m | Device: Heated Humidified High-Flow Nasal Cannula<br>* Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.<br>* Other names: Noninvasive Ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intubation rate | Any placement of an endotracheal tube for any indication within 72 hours of extubation, censored at the first of hospital discharge or 72 hours after extubation. | within 72 hours of extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Mortality rate, or death rate is a measure of the number of deaths | up to 3 months |