Oxygen ToxicityNONSTOPNCT03937622
Northern Survey on Therapeutic Oxygen Prescription
An observational study of Oxygen Toxicity, run by Hannover Medical School at 2 sites in Germany.
Trial summary
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Toxicity
- What is being tested?
- 17 items questionaire
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Jul 2019to 20 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany
Who may be able to join
- Patients with chronic lung disease, age > 18 years
- Established domiciliary LTOT > 4 weeks
- Scheduled for control of oxygen therapy with arterial/capillary
Who cannot join
- No informed consent
- Pulmonary exacerbation within the last 2 weeks
- Signs of heart failure (edema, congestion)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Dep. Respiratory Medicine, Hannover Medical School
Hanover, 30625
Thomas Fuehner, MD, +495115323505, fuehner.thomas@mh-hannover.de
Jens Gottlieb, MD, +495115323505, gottlieb.jens@mh-hannover.de
- Recruiting
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, 30625
Jens Gottlieb, MD, +49-511-532 ext. 3560, gottlieb.jens@mh-hannover.de
Jens Gottlieb, MD
About this study
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.
- Conditions
- Oxygen Toxicity
- Being tested
- 17 items questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 items questionaireOther
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of indication of Long-term Oxygen therapy (LTOT)
Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start2 Jul 2019
- Primary completion20 Jun 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Gottlieb, Prof. Dr. med., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937622
- Sponsor's protocol ID
- Pneumo-O2
- Acronym
- NONSTOP
- Status last verified
- Aug 2019
- First submitted
- 2 May 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of individual participants data
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Survey on Therapeutic Oxygen Prescription
- ClinicalTrials.gov ID
- NCT03937622
- Acronym / sponsor ID
- NONSTOP / Pneumo-O2
- Conditions
- Oxygen Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 6 May 2019 (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.
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany
Key inclusion criteria (3 listed)
- Patients with chronic lung disease, age > 18 years
- Established domiciliary LTOT > 4 weeks
- Scheduled for control of oxygen therapy with arterial/capillary
Key exclusion criteria (3 listed)
- No informed consent
- Pulmonary exacerbation within the last 2 weeks
- Signs of heart failure (edema, congestion)
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 |
|---|---|---|
| 17 items questionaireThis is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire. | Other | – |
Primary outcome
Validation of indication of Long-term Oxygen therapy (LTOT)
Time frame: 12 month
Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No. No sharing of individual participants data
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Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
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Oxygen Toxicity: Mechanisms in Humans
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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.
Jens Gottlieb, Prof. Dr. med. principal investigator
Hannover Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Toxicity, run by Hannover Medical School at 2 sites 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 3 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Thomas Fühner, PD Dr. med. (+49 531595 ext. 431, fühner.thomas@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of indication of Long-term Oxygen therapy (LTOT) (time frame: 12 month). 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 7 Aug 2019.