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

Sponsor
Fu Jen Catholic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03811158
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
50.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: HHHFNC
  • Device: UHFOM
 N/A

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

Study Type:
Interventional
Anticipated 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.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
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Control group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diaphragm electrical activity [2 days]

      In voltage

    Secondary Outcome Measures

    1. PtcO2 & PtcCO2 [2 days]

      In mmHg

    2. Re-intubation rate [2 days]

      In %

    3. Cardiac index [2 days]

      In L/min/m2

    4. Hospital stay [through study completion, an average 3 months]

      In days

    5. ICU stay [through study completion, an average 1 months]

      In days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fu Jen Catholic University Hospital, Fu Jen Catholic University New Taipei City Taiwan 24352

    Sponsors and Collaborators

    • Fu Jen Catholic University

    Investigators

    • Principal Investigator: Ke-Yun Chao, M.Sc, ck_qq@hotmail.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 22, 2019
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Respiratory Insufficiency
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Feb 8, 2022