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Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas (NHFDuet)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AIRVO 2
Sponsored by
Kliniken Essen-Mitte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Georg N Nilius

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nasal High Flow with Optiflow M cannula

Nasal High Flow with Optiflow Duet Cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
December 22, 2022
Last Updated
December 22, 2022
Sponsor
Kliniken Essen-Mitte
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05676502
Brief Title
Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas
Acronym
NHFDuet
Official Title
Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kliniken Essen-Mitte
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal High Flow with Optiflow M cannula
Arm Type
Active Comparator
Arm Description
Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M)
Arm Title
Nasal High Flow with Optiflow Duet Cannula
Arm Type
Active Comparator
Arm Description
Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet)
Intervention Type
Device
Intervention Name(s)
AIRVO 2
Other Intervention Name(s)
Nasal High Flow
Intervention Description
Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.
Primary Outcome Measure Information:
Title
Change in minute ventilation (MV) comparing arm 1 and 2
Description
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L
Time Frame
1.5 hours
Secondary Outcome Measure Information:
Title
Change in respiratory rate (RR) comparing arm 1 and 2
Description
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), RR is calculated. Unit is breath per minute
Time Frame
1.5 hours
Title
Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2
Description
Respiratory effort is measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), (Ti/Te) is calculated.
Time Frame
1.5 hours
Other Pre-specified Outcome Measures:
Title
Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2
Description
SurfEMG is measured with EMG system (ADInstruments, NZ), it represents the neural respiratory drive, max ampltude of EMG, unit is mV
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg N Nilius, Prof. Dr. med
Phone
+49 201 174
Ext
22011
Email
G.Nilius@kem-med.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrike Domanski
Phone
+49 0201 174
Ext
22058
Email
U.Domanski@kem-med.com
Facility Information:
Facility Name
Georg N Nilius
City
Essen
State/Province
NRW
ZIP/Postal Code
45136
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Nilius
Phone
+49 201 174
Ext
22011
Email
G.Nilius@kem-med.com
First Name & Middle Initial & Last Name & Degree
Ulrike Domanski
Phone
+49 201 174
Ext
22058
Email
U.Domanski@kem-med.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

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