COPDNCT05053074
Nasal High Flow (NHF) in COPD - Effects on Ventilation in Wakefulness
A study testing Nasal High Flow (NHF) in people with COPD, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Nasal High Flow (NHF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 27 Feb 2021to 1 Mar 2022
- 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
- Hospitalized COPD patients GOLD (3 and 4) in stable phase after an acute exacerbation.
- Written informed consent is required for participation.
Who cannot join
- Acute respiratory failure with clinical instability or respiratory acidosis defined by pH<7.35
- Severe acute physical illness that does not allow the subject to participate in a clinical trial
- Unable to give consent
- Language, cognitive, or other impairments that may prevent independent completion of questionnaires
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Nasal High Flow (NHF) Bei COPD - Effekte Auf Die Ventilation im Wachzustand
Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Aim of the study is to examine respiratory rate, tidal volume and work of breathing under NHF without the CO2 washout effect.
Read the detailed description
In this controlled randomized crossover trial, 10 stable patients with chronic obstructive respiratory disease (COPD) are treated with Nasal High Flow (NHF) therapy during wakefulness. NHF treatment will inevitably result in increased upper airway washout and thus in a slight reduction of PaCO2 of approximately 2 mmHg. For compensation, a small amount of CO2 is added to the inhaled air during this experimental situation, which keeps the patients' PaCO2 stable. This will allow to examine the effects of NHF therapy on respiratory rate, tidal volume and work of breathing, that are not attributable to the CO2 washout effect.
- Conditions
- COPD
- Being tested
- Nasal High Flow (NHF)
- Keywords
- Nasal High Flow, PaCO2, Tidal Volume, Washout Effect
- 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.
Nasal High Flow (NHF)Device
Also called AIRVO2
Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness.
| Study group | Role | What they receive |
|---|---|---|
| NHF - NHF/CO2 | Experimental | Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) alone, then NHF (30l/min) plus 1% CO2. Receives: Device: Nasal High Flow (NHF) |
| NHF/CO2 - NHF | Experimental | Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) plus 1% CO2 , then NHF (30l/min) alone. Receives: Device: Nasal High Flow (NHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute Ventilation
Difference in respiratory minute volume under NHF versus NHF/CO2.
Measured: up to 1 hour
Secondary outcomes (3)
Tidal Volume
Difference in tidal volume (VT) under NHF versus NHF/CO2
Measured: up to 1 hour
Respiratory Rate
Difference in respiratory rate under NHF versus NHF/CO2.
Measured: up to 1 hour
Transcutaneous pCO2
Difference in transcutaneous pCO2 under NHF versus NHF/CO2.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start27 Feb 2021
- Primary completion12 Nov 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Georg Nilius, Prof DR med, Institut für Pneumologie Hagen Ambrock eV
- Investigators
- Georg Nilius, Professor, Principal investigator, Evang. Kliniken Essen-Mitte gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053074
- Sponsor's protocol ID
- NHFwake2020
- Status last verified
- May 2023
- First submitted
- 13 Sep 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Flow (NHF) Bei COPD - Effekte Auf Die Ventilation im Wachzustand
- ClinicalTrials.gov ID
- NCT05053074
- Acronym / sponsor ID
- NHFwake2020
- Conditions
- COPD
- Keywords
- Nasal High Flow, PaCO2, Tidal Volume, Washout Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Sep 2021 (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.
Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Aim of the study is to examine respiratory rate, tidal volume and work of breathing under NHF without the CO2 washout effect.
Detailed description
In this controlled randomized crossover trial, 10 stable patients with chronic obstructive respiratory disease (COPD) are treated with Nasal High Flow (NHF) therapy during wakefulness. NHF treatment will inevitably result in increased upper airway washout and thus in a slight reduction of PaCO2 of approximately 2 mmHg. For compensation, a small amount of CO2 is added to the inhaled air during this experimental situation, which keeps the patients' PaCO2 stable. This will allow to examine the effects of NHF therapy on respiratory rate, tidal volume and work of breathing, that are not attributable to the CO2 washout effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHF - NHF/CO2 | Experimental | Device: Nasal High Flow (NHF)Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) alone, then NHF (30l/min) plus 1% CO2. |
| NHF/CO2 - NHF | Experimental | Device: Nasal High Flow (NHF)Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) plus 1% CO2 , then NHF (30l/min) alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized COPD patients GOLD (3 and 4) in stable phase after an acute exacerbation.
- Written informed consent is required for participation.
Key exclusion criteria (4 listed)
- Acute respiratory failure with clinical instability or respiratory acidosis defined by pH<7.35
- Severe acute physical illness that does not allow the subject to participate in a clinical trial
- Unable to give consent
- Language, cognitive, or other impairments that may prevent independent completion of questionnaires
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 |
|---|---|---|
| Nasal High Flow (NHF)Also: AIRVO2Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness. | Device | NHF - NHF/CO2, NHF/CO2 - NHF |
Primary outcome
Minute Ventilation
Time frame: up to 1 hour
Difference in respiratory minute volume under NHF versus NHF/CO2.
3 secondary outcomes
Tidal Volume
Time frame: up to 1 hour
Respiratory Rate
Time frame: up to 1 hour
Transcutaneous pCO2
Time frame: up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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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.
Georg Nilius, Professor principal investigator
Evang. Kliniken Essen-Mitte gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow (NHF) in people with COPD, run by Institut für Pneumologie Hagen Ambrock eV 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 2 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute Ventilation (time frame: up to 1 hour). 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 22 May 2023.