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CompletedNCT04564859HHHFNCUpdated Sep 25, 2020

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

An interventional study of Heated Humidified High-Flow Nasal Cannula in Critically Illness, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Completed. Open to participants aged 20 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-25.

Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jan 2017, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Critically Illness
03

In context

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Pregnancy
  • Status post tracheostomy
  • Neuromuscular diseases
  • Signed "do not resuscitate" order
  • Unplanned extubation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceHeated 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.

    Also known as: Noninvasive Ventilation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 72 hours of extubation

Secondary outcomes

  1. Mortality rate

    Mortality rate, or death rate is a measure of the number of deaths

    Time frame: up to 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04564859
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
Fu Jen Catholic University
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 25, 2020

Study contacts

Chen-Chun Lin, MD
study chair · Shin Kong Wu Ho-Su Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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