Clinical trial NCT05676502: Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas
Official title: Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Nasal High Flow (NHF)
High Flow Nasal Cannula (HFNC)
Optiflow
COPD
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2023-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in minute ventilation (MV) comparing arm 1 and 2
timeFrame: 1.5 hours
Secondary outcomes:
measure: Change in respiratory rate (RR) comparing arm 1 and 2
timeFrame: 1.5 hours
measure: Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2
timeFrame: 1.5 hours
Other outcomes:
measure: Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2
timeFrame: 1.5 hours
Locations:
city: Essen
country: Germany
facility: Georg N Nilius
state: NRW
Study officials:
References: