Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas (NHFDuet)

Kliniken Essen-Mitte

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: AIRVO 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05676502

NHFDuet 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nasal High Flow with Optiflow M cannula

Active Comparator group

Description:

Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M)

Treatment:

Device: AIRVO 2

Nasal High Flow with Optiflow Duet Cannula

Active Comparator group

Description:

Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet)

Treatment:

Device: AIRVO 2