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

Not Applicable

Completed

• Conditions: Critically Illness
• Interventions: Device: Heated Humidified High-Flow Nasal Cannula

• Registration Number: NCT04564859
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-13
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive Ventilation group	Heated Humidified High-Flow Nasal Cannula	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
Heated Humidified High-Flow Nasal Cannula group	Heated Humidified High-Flow Nasal Cannula	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

Primary Outcome Measures

Name	Time	Method
Re-intubation rate	within 72 hours of extubation	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.

Secondary Outcome Measures

Name	Time	Method
Mortality rate	up to 3 months	Mortality rate, or death rate is a measure of the number of deaths