Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05676502
• Lead Sponsor: Kliniken Essen-Mitte

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.

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-01-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Georg N Nilius; 🇩🇪 Essen, NRW, Germany