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

Not Applicable

Terminated

• Conditions: Chronic Obstructive Lung Disease; Respiratory Insufficiency
• Interventions: Device: UHFOM; Device: HHHFNC

• Registration Number: NCT03811158
• Lead Sponsor: Fu Jen Catholic University

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.

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 Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UHFOM group	UHFOM	On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
HHHFNC group	HHHFNC	On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min

Primary Outcome Measures

Name	Time	Method
Diaphragm electrical activity	2 days	In voltage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan