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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564859
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Fu Jen Catholic University
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Critically Illness Device: Heated Humidified High-Flow Nasal Cannula Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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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 Name: 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 Name: Noninvasive Ventilation


Outcome Measures
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Primary Outcome Measures :
  1. Re-intubation rate [ Time Frame: 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 :
  1. Mortality rate [ Time Frame: up to 3 months ]
    Mortality rate, or death rate is a measure of the number of deaths


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564859


Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Fu Jen Catholic University
Investigators
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Study Chair: Chen-Chun Lin, MD Shin Kong Wu Ho-Su Memorial Hospital
More Information
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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT04564859    
Other Study ID Numbers: SKH-8302-106-NDR-05
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No