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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Obstructive Lung Disease, Respiratory Insufficiency

Intervention / Treatment
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* Device: HHHFNC
* Device: UHFOM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AE of COPD received intubation and ready to be weaning P/F ratio > 200 during SBT before extubation Exclusion Criteria: Unable to insert NG tube Refuse to re-intubated when respiratory failure after extubation Planned NIV use after extubation Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HHHFNC group<br>On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min | Device: HHHFNC<br>* 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.<br>* Other names: Study group;|
| Sham Comparator: UHFOM group<br>On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min | Device: UHFOM<br>* 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.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm electrical activity | In voltage | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PtcO2 & PtcCO2 | In mmHg | 2 days | 
| Re-intubation rate | In % | 2 days | 
| Cardiac index | In L/min/m2 | 2 days | 
| Hospital stay | In days | through study completion, an average 3 months | 
| ICU stay | In days | through study completion, an average 1 months |