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

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

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.

Study Overview

• Status: Completed
• Conditions: Critically Illness
• Intervention / Treatment: Device: Heated Humidified High-Flow Nasal Cannula

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Noninvasive Ventilation group; 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; 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.; Other Names: Noninvasive Ventilation
ACTIVE_COMPARATOR: Heated Humidified High-Flow Nasal Cannula group; 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; 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.; Other Names: Noninvasive Ventilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Collaborators: Fu Jen Catholic University
• Investigators: Study Chair: Chen-Chun Lin, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (ACTUAL): September 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SKH-8302-106-NDR-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No