Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: AIRVO 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal High Flow with Optiflow M cannula<br>Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M) | Device: AIRVO 2<br>* Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.<br>* Other names: Nasal High Flow;|
| Active Comparator: Nasal High Flow with Optiflow Duet Cannula<br>Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet) | Device: AIRVO 2<br>* Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.<br>* Other names: Nasal High Flow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minute ventilation (MV) comparing arm 1 and 2 | Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L | 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respiratory rate (RR) comparing arm 1 and 2 | Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), RR is calculated. Unit is breath per minute | 1.5 hours | 
| Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2 | Respiratory effort is measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), (Ti/Te) is calculated. | 1.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD