Safety of NHF in Acute Hypercapnic AECOPDNCT03523481
NHF in Acute Hypercapnic Acute Exacerbation of COPD
An observational study of Safety of NHF in Acute Hypercapnic AECOPD, run by Jens Bräunlich, MD at 1 site in Germany.
Trial summary
Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or refusal of therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety of NHF in Acute Hypercapnic AECOPD
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2018to 30 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with AECOPD and failure of NIV therapy
Who may be able to join
- pH < 7,38
- hypercapnic AECOPD
Who cannot join
- Need of intubation
Trial locations and contacts
1 site in 1 country.
About this study
Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or refusal of therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NHF use | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH
Increase in pH
Measured: up to 24 hours
Secondary outcomes (1)
pCO2
Decrease in pCO2
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 May 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of NHF in Acute Hypercapnic AECOPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Bräunlich, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Bräunlich, MD, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523481
- Sponsor's protocol ID
- 2
- Status last verified
- Jun 2018
- First submitted
- 2 Apr 2018
- Last updated
- 25 Jun 2018
- 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 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHF in Acute Hypercapnic Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT03523481
- Acronym / sponsor ID
- 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jens Bräunlich, MDUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 14 May 2018 (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.
Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or refusal of therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHF use | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with AECOPD and failure of NIV therapy
Key inclusion criteria (2 listed)
- pH < 7,38
- hypercapnic AECOPD
Key exclusion criteria (1 listed)
- Need of intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pH
Time frame: up to 24 hours
Increase in pH
1 secondary outcome
pCO2
Time frame: up to 24 hours
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 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety of NHF in Acute Hypercapnic AECOPD, run by Jens Bräunlich, MD 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 1 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 Jun 2018. 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?
pH (time frame: up to 24 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 25 Jun 2018.