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Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

NCT ID: NCT05676502

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Nasal High Flow (NHF) High Flow Nasal Cannula (HFNC) Optiflow COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal High Flow with Optiflow M cannula

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

Group Type ACTIVE_COMPARATOR

AIRVO 2

Intervention Type DEVICE

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

Nasal High Flow with Optiflow Duet Cannula

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

Group Type ACTIVE_COMPARATOR

AIRVO 2

Intervention Type DEVICE

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

Interventions

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AIRVO 2

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

Intervention Type DEVICE

Other Intervention Names

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Nasal High Flow

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role collaborator

Kliniken Essen-Mitte

OTHER

Sponsor Role lead

Responsible Party

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Georg Nilius, Prof. Dr. med

Head of Department of Pneumology, PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Georg N Nilius

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Georg N Nilius, Prof. Dr. med

Role: CONTACT

Phone: +49 201 174

Email: [email protected]

Ulrike Domanski

Role: CONTACT

Phone: +49 0201 174

Email: [email protected]

Facility Contacts

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Georg Nilius

Role: primary

Ulrike Domanski

Role: backup

Other Identifiers

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NHFDuet 2022

Identifier Type: -

Identifier Source: org_study_id