Clinical trial NCT03811158: The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Respiratory Insufficiency
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Diaphragm electrical activity
timeFrame: 2 days
Secondary outcomes:
measure: PtcO2 & PtcCO2
timeFrame: 2 days
measure: Re-intubation rate
timeFrame: 2 days
measure: Cardiac index
timeFrame: 2 days
measure: Hospital stay
timeFrame: through study completion, an average 3 months
measure: ICU stay
timeFrame: through study completion, an average 1 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: ck_qq@hotmail.com
name: Ke-Yun Chao, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2014 Nov;16(11):718-22.
citation: Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
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 therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.