Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

Chronic Obstructive Pulmonary Disease Clinical Trial

— NHFDuet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676502
• Other study ID #: NHFDuet 2022
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Kliniken Essen-Mitte
• Contact: Georg N Nilius, Prof. Dr. med
• Phone: +49 201 174
• Email: G.Nilius[@]kem-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Germany	Georg N Nilius	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Kliniken Essen-Mitte	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2	SurfEMG is measured with EMG system (ADInstruments, NZ), it represents the neural respiratory drive, max ampltude of EMG, unit is mV	1.5 hours
Primary	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	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
Secondary	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