Chronic Obstructive Pulmonary DiseaseNHFDuetNCT05676502
Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas
A study testing AIRVO 2 in people with Chronic Obstructive Pulmonary Disease, run by Kliniken Essen-Mitte at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AIRVO 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jan 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation
- Inpatients with COPD GOLD (2, 3 and 4)
- Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Georg N Nilius
Essen, North Rhine-Westphalia, 45136
Georg Nilius, +49 201 174 ext. 22011, G.Nilius@kem-med.com
Ulrike Domanski, +49 201 174 ext. 22058, U.Domanski@kem-med.com
About this study
Official title: Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AIRVO 2
- Keywords
- Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRVO 2Device
Also called Nasal High Flow
Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High Flow with Optiflow M cannula | Active comparator | Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M) Receives: Device: AIRVO 2 |
| Nasal High Flow with Optiflow Duet Cannula | Active comparator | Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet) Receives: Device: AIRVO 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 hours
Secondary outcomes (2)
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
Measured: 1.5 hours
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.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start19 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Georg Nilius, Prof. Dr. med, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676502
- Sponsor's protocol ID
- NHFDuet 2022
- Acronym
- NHFDuet
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)
- ClinicalTrials.gov ID
- NCT05676502
- Acronym / sponsor ID
- NHFDuet / NHFDuet 2022
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Nasal High Flow (NHF), High Flow Nasal Cannula (HFNC), Optiflow, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal High Flow with Optiflow M cannula | Active comparator | Device: AIRVO 2Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M) |
| Nasal High Flow with Optiflow Duet Cannula | Active comparator | Device: AIRVO 2Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation
- Inpatients with COPD GOLD (2, 3 and 4)
- Informed Consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIRVO 2Also: Nasal High FlowPatients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h. | Device | Nasal High Flow with Optiflow Duet Cannula, Nasal High Flow with Optiflow M cannula |
Primary outcome
Change in minute ventilation (MV) comparing arm 1 and 2
Time frame: 1.5 hours
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L
2 secondary outcomes
Change in respiratory rate (RR) comparing arm 1 and 2
Time frame: 1.5 hours
Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2
Time frame: 1.5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRVO 2 in people with Chronic Obstructive Pulmonary Disease, run by Kliniken Essen-Mitte at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg N Nilius, Prof. Dr. med (+49 201 174 ext. 22011, G.Nilius@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minute ventilation (MV) comparing arm 1 and 2 (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.