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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564859
Other study ID # SKH-8302-106-NDR-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2019

Study information

Verified date September 2020
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shin Kong Wu Ho-Su Memorial Hospital Fu Jen Catholic University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mortality rate Mortality rate, or death rate is a measure of the number of deaths up to 3 months
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