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

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03811158
• Other study ID #: PL-201705001-M
• Status: Terminated
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J — View Citation

Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen — View Citation

Stéphan F, Barrucand B, Petit P, Rézaiguia-Delclaux S, Médard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Bérard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm electrical activity	In voltage	2 days
Secondary	PtcO2 & PtcCO2	In mmHg	2 days
Secondary	Re-intubation rate	In %	2 days
Secondary	Cardiac index	In L/min/m2	2 days
Secondary	Hospital stay	In days	through study completion, an average 3 months
Secondary	ICU stay	In days	through study completion, an average 1 months