HealthyNCT00866541
Flow Proportional Pressure Support in Volunteers
A study testing artificial increased resistance (flow proportional pressure support) in people with Healthy, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- artificial increased resistance (flow proportional pressure support)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 18 years
- ASA I and II
Who cannot join
- refusal of written informed consent
- chronic respiratory or cardiac diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Freiburg
Freiburg im Breisgau, 79106
Daniel Steinmann, MD, 0049 761 270 2329, daniel.steinmann@uniklinik-freiburg.de
Daniel Steinmann, MD
About this study
Official title: Flow Proportional Pressure Support as a New Mode of Spontaneous Breathing Assist - Evaluation of Objective and Subjective Measured Data in Volunteers
Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.
- Conditions
- Healthy
- Being tested
- artificial increased resistance (flow proportional pressure support)
- Keywords
- resistance, flow proportional pressure support, pressure support ventilation, volunteers, assistant breathing, breathing comfort and objective breathing data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial increased resistance (flow proportional pressure support)Device
respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Experimental | artificial increased respiratory resistance Receives: Device: artificial increased resistance (flow proportional pressure support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure support
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Steinmann, MD, Principal investigator, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866541
- Sponsor's protocol ID
- 327/07
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mols G, Vetter T, Haberthur C, Geiger K, Guttmann J. Breathing pattern and perception at different levels of volume assist and pressure support in volunteers. Crit Care Med. 2001 May;29(5):982-8. doi: 10.1097/00003246-200105000-00018.
PubMed 11378608Mols G, von Ungern-Sternberg B, Rohr E, Haberthur C, Geiger K, Guttmann J. Respiratory comfort and breathing pattern during volume proportional assist ventilation and pressure support ventilation: a study on volunteers with artificially reduced compliance. Crit Care Med. 2000 Jun;28(6):1940-6. doi: 10.1097/00003246-200006000-00042.
PubMed 10890645Mols G, Rohr E, Benzing A, Haberthur C, Geiger K, Guttmann J. Breathing pattern associated with respiratory comfort during automatic tube compensation and pressure support ventilation in normal subjects. Acta Anaesthesiol Scand. 2000 Mar;44(3):223-30. doi: 10.1034/j.1399-6576.2000.440302.x.
PubMed 10714832Guttmann J, Bernhard H, Mols G, Benzing A, Hofmann P, Haberthur C, Zappe D, Fabry B, Geiger K. Respiratory comfort of automatic tube compensation and inspiratory pressure support in conscious humans. Intensive Care Med. 1997 Nov;23(11):1119-24. doi: 10.1007/s001340050467.
PubMed 9434916
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Proportional Pressure Support as a New Mode of Spontaneous Breathing Assist - Evaluation of Objective and Subjective Measured Data in Volunteers
- ClinicalTrials.gov ID
- NCT00866541
- Acronym / sponsor ID
- 327/07
- Conditions
- Healthy
- Keywords
- resistance, flow proportional pressure support, pressure support ventilation, volunteers, assistant breathing, breathing comfort and objective breathing data
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- First posted
- 20 Mar 2009 (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.
Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Device: artificial increased resistance (flow proportional pressure support)artificial increased respiratory resistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18 years
- ASA I and II
Key exclusion criteria (2 listed)
- refusal of written informed consent
- chronic respiratory or cardiac diseases
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 |
|---|---|---|
| artificial increased resistance (flow proportional pressure support)respiratory resistance is increased by interpose of an artificial resistance tool in the in- and expiratory airways of the mechanical respirator | Device | volunteers |
Primary outcome
pressure support
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
- Background: PubMed 11378608Mols G, Vetter T, Haberthur C, Geiger K, Guttmann J. Breathing pattern and perception at different levels of volume assist and pressure support in volunteers. Crit Care Med. 2001 May;29(5):982-8. doi: 10.1097/00003246-200105000-00018.
- Background: PubMed 10890645Mols G, von Ungern-Sternberg B, Rohr E, Haberthur C, Geiger K, Guttmann J. Respiratory comfort and breathing pattern during volume proportional assist ventilation and pressure support ventilation: a study on volunteers with artificially reduced compliance. Crit Care Med. 2000 Jun;28(6):1940-6. doi: 10.1097/00003246-200006000-00042.
- Background: PubMed 10714832Mols G, Rohr E, Benzing A, Haberthur C, Geiger K, Guttmann J. Breathing pattern associated with respiratory comfort during automatic tube compensation and pressure support ventilation in normal subjects. Acta Anaesthesiol Scand. 2000 Mar;44(3):223-30. doi: 10.1034/j.1399-6576.2000.440302.x.
- Background: PubMed 9434916Guttmann J, Bernhard H, Mols G, Benzing A, Hofmann P, Haberthur C, Zappe D, Fabry B, Geiger K. Respiratory comfort of automatic tube compensation and inspiratory pressure support in conscious humans. Intensive Care Med. 1997 Nov;23(11):1119-24. doi: 10.1007/s001340050467.
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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.
Daniel Steinmann, MD principal investigator
University Medical Center Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial increased resistance (flow proportional pressure support) in people with Healthy, run by University Hospital Freiburg 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 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: status not confirmed, as of the sponsor's last update on 20 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Steinmann, MD (0049 761 270 2329, daniel.steinmann@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure support (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00866541, which also lists 4 linked publications.
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 20 Mar 2009.