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The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD

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ClinicalTrials.gov Identifier: NCT03811158
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Ke-Yun, Chao, Fu Jen Catholic University

Study Description
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Brief Summary:
Patients with COPD exacerbation usually need respiratory support after extubation. Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. There are no clinical data of diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as post-extubation respiratory support.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Lung Disease Respiratory Insufficiency Device: HHHFNC Device: UHFOM Not Applicable

Detailed Description:
Objectives： The aim of this study is to compare the Edi level and cardiopulmonary parameters between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients with post-extubation respiratory support. This is the first clinical trial to investigate and analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM in adult patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover. The primary outcome measure is the diaphragm electrical activity. The secondary outcome measures include the cardiopulmonary function, length of hospital stay, and re-intubation rate.
Masking: Single (Investigator)
Masking Description: All data will be decoded before biostatics analysis
Primary Purpose: Treatment
Official Title: The Diaphragm Activity Level and Cardiopulmonary Function Between Heated Humidified High-Flow Nasal Cannula and Unheated Humidified High-Flow Oxygen Mask in Acute Exacerbation of COPD Patients as Post-Extubation Respiratory Support
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

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: HHHFNC group
On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min
 Device: HHHFNC
Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
Other Name: Study group
Sham Comparator: UHFOM group
On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
 Device: UHFOM
Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
Other Name: Control group


Outcome Measures
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Primary Outcome Measures :
  1. Diaphragm electrical activity [ Time Frame: 2 days ]
    In voltage


Secondary Outcome Measures :
  1. PtcO2 & PtcCO2 [ Time Frame: 2 days ]
    In mmHg

  2. Re-intubation rate [ Time Frame: 2 days ]
    In %

  3. Cardiac index [ Time Frame: 2 days ]
    In L/min/m2

  4. Hospital stay [ Time Frame: through study completion, an average 3 months ]
    In days

  5. ICU stay [ Time Frame: through study completion, an average 1 months ]
    In days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. AE of COPD received intubation and ready to be weaning
  2. P/F ratio > 200 during SBT before extubation

Exclusion Criteria:

  1. Unable to insert NG tube
  2. Refuse to re-intubated when respiratory failure after extubation
  3. Planned NIV use after extubation
  4. Pregnancy
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): NCT03811158


Contacts
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Contact: Ke-Yun Chao, M.Sc +886-952-909-103 ck_qq@hotmail.com

Locations
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Taiwan
Fu Jen Catholic University Hospital, Fu Jen Catholic University Recruiting
New Taipei City, Taiwan, 24352
Contact: Ke-Yun Chao, M.Sc    +886952909103    ck_qq@hotmail.con   
Principal Investigator: Ke-Yun Chao, M.Sc         
Sponsors and Collaborators
Fu Jen Catholic University
Investigators
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Principal Investigator: Ke-Yun Chao, M.Sc ck_qq@hotmail.com
More Information
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Publications of Results:

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Responsible Party: Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University
ClinicalTrials.gov Identifier: NCT03811158    
Other Study ID Numbers: PL-201705001-M
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Insufficiency
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Valve Insufficiency
 Respiratory Tract Diseases
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases