Pulmonary Disease, Chronic ObstructiveNCT02083120
Efficacy and Physiology of Nasal High Flow Therapy
A study testing NHF therapy and Long term Oxygen Therapy (LOT) in people with Pulmonary Disease, Chronic Obstructive, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet. The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- NHF therapy and Long term Oxygen Therapy (LOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to 1 Nov 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80
- Male and female
- COPD patients with chronic respiratory insufficiency (pH >7.35 and PCO2 > 50mmHg)
- Stable respiratory situation
Who cannot join
- Decompensated heart, liver or kidney failure.
- Pregnancy or nursing period
- Participation in another clinical trial within the last 4 weeks
- Drug abuse
- Incapable of giving consent
- Known obstructive sleep apnea syndrome (OSA) (AHI>10)
- noninvasive ventilation (NIV) therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure
The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.
The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).
Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.
Read the detailed description
Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.
Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.
Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.
Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.
All patients will be monitored for the next 12 month. After 6 month there will be a control phone call.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- NHF therapy, Long term Oxygen Therapy (LOT)
- Keywords
- high flow, COPD, AIRVO
- 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.
NHF therapyDevice
Also called AIRVO 2, myAIRVO 2, PT101, PT100
AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.
Long term Oxygen Therapy (LOT)Other
Also called supplemental oxygen
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
| Study group | Role | What they receive |
|---|---|---|
| nasal High Flow and Oxygen | Experimental | overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home Receives: Device: NHF therapy; Other: Long term Oxygen Therapy (LOT) |
| Long term Oxygen Therapy (LOT) | Active comparator | individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home Receives: Other: Long term Oxygen Therapy (LOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean overnight transcutaneous PCO2
In two baseline measurements the aim is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.
Primary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent >50 mmHg.
Measured: baseline
mean overnight transcutaneous PCO2
In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.
Measured: after 4 weeks
mean overnight transcutaneous PCO2
All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.
Measured: after 12 month
Secondary outcomes (1)
quality of life with Saint Georges Respiratory Questionnaire (SGRQ)
SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Measured: after 4 weeks, 8 weeks and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Georg Nilius, Helios Klinik Ambrock
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Ambrock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083120
- Sponsor's protocol ID
- AIRVOhome
- Status last verified
- Feb 2019
- First submitted
- 7 Mar 2014
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT02083120
- Acronym / sponsor ID
- AIRVOhome
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- high flow, COPD, AIRVO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Apr 2014
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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 effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.
The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).
Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.
Detailed description
Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.
Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.
Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.
Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.
All patients will be monitored for the next 12 month. After 6 month there will be a control phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal High Flow and Oxygen | Experimental | Device: NHF therapy, Other: Long term Oxygen Therapy (LOT)overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home |
| Long term Oxygen Therapy (LOT) | Active comparator | Other: Long term Oxygen Therapy (LOT)individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-80
- Male and female
- COPD patients with chronic respiratory insufficiency (pH >7.35 and PCO2 > 50mmHg)
- Stable respiratory situation
Key exclusion criteria (7 listed)
- Decompensated heart, liver or kidney failure.
- Pregnancy or nursing period
- Participation in another clinical trial within the last 4 weeks
- Drug abuse
- Incapable of giving consent
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 |
|---|---|---|
| NHF therapyAlso: AIRVO 2, myAIRVO 2, PT101, PT100AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared. | Device | nasal High Flow and Oxygen |
| Long term Oxygen Therapy (LOT)Also: supplemental oxygenOxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%. | Other | Long term Oxygen Therapy (LOT), nasal High Flow and Oxygen |
Primary outcome
mean overnight transcutaneous PCO2
Time frame: baseline
In two baseline measurements the aim is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order. Primary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent >50 mmHg.
mean overnight transcutaneous PCO2
Time frame: after 4 weeks
In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.
mean overnight transcutaneous PCO2
Time frame: after 12 month
All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.
1 secondary outcome
quality of life with Saint Georges Respiratory Questionnaire (SGRQ)
Time frame: after 4 weeks, 8 weeks and 12 month
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 11 Feb 2019.
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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, MD principal investigator
Helios Klinik Ambrock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHF therapy and Long term Oxygen Therapy (LOT) in people with Pulmonary Disease, Chronic Obstructive, 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 4 inclusion and 7 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 11 Feb 2019. 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?
mean overnight transcutaneous PCO2 (time frame: baseline). The study lists 3 primary outcomes in all. 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 11 Feb 2019.