Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD
Brief summary
The aim of this controlled randomized crossover study is to compare the physiological effects of nasal high flow therapy (NHF) with 2 different nasal cannulas in patients with exacerbated chronic obstructive pulmonary disease (ECOPD) and chronic respiratory failure. 20 patients will be treated with NHF therapy (Airvo, Fisher&Paykel Healthcare, NZ) during wakefulness. Physiological measuremends will take place over three perdiods (visits). One period without NHF, one with NHF via standard cannula (Optiflow M) and one with asymmetrical cannula (Optiflow Duet) in randomised order.
Detailed description
Background: Nasal High Flow (NHF) therapy had shown to increase airway pressure, reduce dead space, and improve mucociliary clearance and gas exchange in patients suffering from chronic obstructive pulmonary disease (COPD). The long-term and short-term physiological aspects of NHF are subject of ongoing research. Different flow rates and cannula sizes have been studied and found to yield different therapeutic effects. Larger sized cannulas tend to seal the nares and produce increased positive airway pressure, while smaller cannulas increase the washout effect. Currently, a new cannula is available, with one smaller and one larger opening (Optiflow+ Duet, Fisher&Paykel Healthcare, NZ). Procedure: Following a baseline period without high flow therapy, NHF (35L/min) will be applied via the nasal cannula (Duet or Standard in randomized order). After a wash out phase, the NHF interface will be replaced for another measurement with the respective other cannula (Standard or Duet). Respiratory rate, tidal volume, minute ventilation, inhalation to exhalation ratio (Ti/Te), transcutaneous pCO2 and intercostal EMG will be recorded during each partial measurement.
Interventions
DEVICEAIRVO 2
Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.
Sponsors
Fisher and Paykel Healthcare
Kliniken Essen-Mitte
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation * Inpatients with COPD GOLD (2, 3 and 4) * Informed Consent
Exclusion criteria
* Acute respiratory insuffiency with respiratory acidosis (pH\<7.35) * Severe acute physical disease, that do not allow the subject to participate in a clinical trial * Language, cognitive, or other barriers that make study participation impossible * Pregnancy or Nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in minute ventilation (MV) comparing arm 1 and 2 | 1.5 hours | Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in respiratory rate (RR) comparing arm 1 and 2 | 1.5 hours | Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), RR is calculated. Unit is breath per minute |
| Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2 | 1.5 hours | Respiratory effort is measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), (Ti/Te) is calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2 | 1.5 hours | SurfEMG is measured with EMG system (ADInstruments, NZ), it represents the neural respiratory drive, max ampltude of EMG, unit is mV |
Countries
Germany
Contacts
Primary ContactGeorg N Nilius, Prof. Dr. med
Backup ContactUlrike Domanski
Outcome results
None listed