NHFDuet: Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

Sponsor

Kliniken Essen-Mitte (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05676502

Collaborator

Fisher and Paykel Healthcare (Industry)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: AIRVO 2	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Nasal High Flow with Optiflow M cannula

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

Device: AIRVO 2

Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.

Other Names:

Nasal High Flow

Active Comparator: Nasal High Flow with Optiflow Duet Cannula

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

Device: AIRVO 2

Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.

Other Names:

Nasal High Flow

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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