Chronic Obstructive Lung Disease, Respiratory Insufficiency
Conditions
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.
Interventions
DEVICEHHHFNC
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.
DEVICEUHFOM
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.
Sponsors
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
All data will be decoded before biostatics analysis
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm electrical activity | 2 days | In voltage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PtcO2 & PtcCO2 | 2 days | In mmHg |
| Re-intubation rate | 2 days | In % |
| Cardiac index | 2 days | In L/min/m2 |
| Hospital stay | through study completion, an average 3 months | In days |
| ICU stay | through study completion, an average 1 months | In days |
Countries
Taiwan
Outcome results
None listed