COPDNCT01499550
Nocturnal Transnasal Insufflation (nTNI)
A study testing humidified transnasal insufflation (TNI20oxy) and overnight oxygen treatment with individual flow rate in people with COPD and Hypercapnia, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- COPD, Hypercapnia
- What is being tested?
- humidified transnasal insufflation (TNI20oxy) and overnight oxygen treatment with individual flow rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jul 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypercapnia in Routine Blood Gas Analysis with > 50 mmHg PCO2
- Clinically stable respiratory situation
- Treatment on normal ward possible
Who cannot join
- Before known obstructive sleep apnea syndrome (OSA)
- A found OSA during study means no exclusion
- Any other severe or acute physical illness which requires intensive medical care
- Acute hypercapnic decompensation with pH < 7.30 in capillary Blood Gas Analysis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Klinik Hagen Ambrock
Hagen, North Rhine-Westphalia, 58091
About this study
Official title: Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia
On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.
Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.
- Conditions
- COPD, Hypercapnia
- Being tested
- humidified transnasal insufflation (TNI20oxy), overnight oxygen treatment with individual flow rate
- Keywords
- transnasal high flow therapy, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humidified transnasal insufflation (TNI20oxy)Device
Also called TNI20oxy
The alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.
overnight oxygen treatment with individual flow rateOther
The patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.
| Study group | Role | What they receive |
|---|---|---|
| TNI application | Experimental | In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min). Receives: Device: humidified transnasal insufflation (TNI20oxy) |
| Oxygen treatment | Active comparator | Long term oxygen treatment (LOT) is the routine treatment in patients suffering from COPD. In this study arm the patient is treated with his individual oxygen flow rate. Receives: Other: overnight oxygen treatment with individual flow rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO2 decrease
During the study nights the patients PCO2 value is measured transcutaneous as well as by capillary blood gas analyses (BGA) in the evening and in the morning. The differences in PCO2 values of the morning BGA will be compared, a PCO2 decrease is supposed to be assessed under TNI treatment.
Measured: within 2 days
Secondary outcomes (1)
Changes of breathing pattern
Changes of breathing pattern and breahing frequency will be recorded during the nights and means and course evaluated. Breathing Frequency is supposed to decrease under TNI treatment
Measured: within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TNI Medical AG
- Responsible party
- Principal investigator, Georg Nilius, Institut für Pneumologie Hagen Ambrock eV
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499550
- Sponsor's protocol ID
- nTNI2011
- Status last verified
- Sep 2012
- First submitted
- 3 Nov 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Transnasal Insufflation in Patients With COPD and Hypercapnia
- ClinicalTrials.gov ID
- NCT01499550
- Acronym / sponsor ID
- nTNI2011
- Conditions
- COPD, Hypercapnia
- Keywords
- transnasal high flow therapy, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- TNI Medical AG
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Dec 2011 (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.
On the basis of different studies the long term oxygen treatment is deemed to be routine treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation. Several prospective randomized studies have shown a reduction of acute mortality as result. But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary overinflation or the appearance of depressions or rather anxiety disorders are possible causes. On the other hand patients may not notice any subjective improvement of symptoms and won't accept the burden of a tight fitting mask during the night. The aim of the present study is to determine the effect on gas exchange of a nocturnal transnasal application of an oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is compared to a nocturnal transnasal application of oxygen alone in randomized order for at least 6 hours each night.
Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements, breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At begin and end of each measurement night a capillary blood gas analysis is made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNI application | Experimental | Device: humidified transnasal insufflation (TNI20oxy)In this study arm the patient is treated with humidified transnasal high flow (TNI) plus oxygen (result flow: 20 L/min). |
| Oxygen treatment | Active comparator | Other: overnight oxygen treatment with individual flow rateLong term oxygen treatment (LOT) is the routine treatment in patients suffering from COPD. In this study arm the patient is treated with his individual oxygen flow rate. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypercapnia in Routine Blood Gas Analysis with > 50 mmHg PCO2
- Clinically stable respiratory situation
- Treatment on normal ward possible
Key exclusion criteria (4 listed)
- Before known obstructive sleep apnea syndrome (OSA)
- A found OSA during study means no exclusion
- Any other severe or acute physical illness which requires intensive medical care
- Acute hypercapnic decompensation with pH < 7.30 in capillary Blood Gas Analysis
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 |
|---|---|---|
| humidified transnasal insufflation (TNI20oxy)Also: TNI20oxyThe alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night. | Device | TNI application |
| overnight oxygen treatment with individual flow rateThe patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night. | Other | Oxygen treatment |
Primary outcome
PCO2 decrease
Time frame: within 2 days
During the study nights the patients PCO2 value is measured transcutaneous as well as by capillary blood gas analyses (BGA) in the evening and in the morning. The differences in PCO2 values of the morning BGA will be compared, a PCO2 decrease is supposed to be assessed under TNI treatment.
1 secondary outcome
Changes of breathing pattern
Time frame: within 2 days
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 25 Sep 2012.
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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 Hagen Ambrock, Ambrocker Weg 60, D58091 Hagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing humidified transnasal insufflation (TNI20oxy) and overnight oxygen treatment with individual flow rate in people with COPD and Hypercapnia, 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 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: finished, as of the sponsor's last update on 25 Sep 2012. 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?
PCO2 decrease (time frame: within 2 days). 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 25 Sep 2012; AzTrials last refreshed its copy on 1 Nov 2026.