Face MaskFFP-O2NCT05931016
Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
An observational study of Face Mask and Longterm Oxygen Therapy, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Face Mask, Longterm Oxygen Therapy
- What is being tested?
- 6-MWT and Spiroergometry
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2023to 31 Dec 2023
- 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 with known lung disease hospitalized at normal wards.
Who may be able to join
- Known lung disease and
- LTOT
- informed consent
Who cannot join
- Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
- Acute exacerbation of lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.
In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.
- Conditions
- Face Mask, Longterm Oxygen Therapy
- Being tested
- 6-MWT, Spiroergometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-MWTDiagnostic test
Also called Six minutes walk test
Measurement of saturation and blood gas parameters under 6-MWT with different masks.
SpiroergometryDiagnostic test
Measurement of saturation and blood gas parameters under spiroergometry with different masks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with known lung disease and LTOT (long term oxygen therapy) | Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT Receives: Diagnostic Test: 6-MWT; Diagnostic Test: Spiroergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in capillary oxygen partial pressure
Measured: At the end of 6-MWT or spiroergometry
Increase in capillary carbon dioxide partial pressure
Measured: At the end of 6-MWT or spiroergometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start26 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face MaskStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Malfertheiner, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931016
- Sponsor's protocol ID
- 22-3165-101
- Acronym
- FFP-O2
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
- ClinicalTrials.gov ID
- NCT05931016
- Acronym / sponsor ID
- FFP-O2 / 22-3165-101
- Conditions
- Face Mask, Longterm Oxygen Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Jul 2023 (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.
The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.
In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with known lung disease and LTOT (long term oxygen therapy) | – | Diagnostic Test: 6-MWT, Diagnostic Test: SpiroergometryPatients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known lung disease hospitalized at normal wards.
Key inclusion criteria (3 listed)
- Known lung disease and
- LTOT
- informed consent
Key exclusion criteria (2 listed)
- Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
- Acute exacerbation of lung disease
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 |
|---|---|---|
| 6-MWTAlso: Six minutes walk testMeasurement of saturation and blood gas parameters under 6-MWT with different masks. | Diagnostic test | Patients with known lung disease and LTOT (long term oxygen therapy) |
| SpiroergometryMeasurement of saturation and blood gas parameters under spiroergometry with different masks. | Diagnostic test | Patients with known lung disease and LTOT (long term oxygen therapy) |
Primary outcome
Increase in capillary oxygen partial pressure
Time frame: At the end of 6-MWT or spiroergometry
Increase in capillary carbon dioxide partial pressure
Time frame: At the end of 6-MWT or spiroergometry
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 5 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 Face Mask and Longterm Oxygen Therapy, run by University Hospital Regensburg 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 2 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 5 Feb 2024. 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?
Increase in capillary oxygen partial pressure (time frame: At the end of 6-MWT or spiroergometry). The study lists 2 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 5 Feb 2024.