Pulmonary Gas ExchangeNCT01686984
Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease
A study testing Altered breath in people with Pulmonary Gas Exchange and Carbon Dioxide, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease. The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Gas Exchange, Carbon Dioxide
- What is being tested?
- Altered breath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to May 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No known primary lung disease
Who cannot join
- Primary lung disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of Brain, Heart and Lungs, Neurosurgical Clinic, Skane University Hospital, Lund
Lund, Skåne County, 22185
About this study
The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease.
The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.
- Conditions
- Pulmonary Gas Exchange, Carbon Dioxide
- Being tested
- Altered breath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altered breathOther
| Study group | Role | What they receive |
|---|---|---|
| Altered breath | Experimental | The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath. Receives: Other: Altered breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon dioxide elimination in a ventilator assisted breath.
Measured: 30 minutes
Secondary outcomes (1)
Blood CO2 concentration.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Gas ExchangeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikael Bodelsson, Professor, Principal investigator, Division of Anesthesia, Skane University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686984
- Sponsor's protocol ID
- 2012/381
- Status last verified
- May 2015
- First submitted
- 13 Sep 2012
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.
PubMed 27440637
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease
- ClinicalTrials.gov ID
- NCT01686984
- Acronym / sponsor ID
- 2012/381
- Conditions
- Pulmonary Gas Exchange, Carbon Dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Sep 2012 (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.
The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease.
The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altered breath | Experimental | Other: Altered breathThe group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No known primary lung disease
Key exclusion criteria (1 listed)
- Primary 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 |
|---|---|---|
| Altered breath | Other | Altered breath |
Primary outcome
Carbon dioxide elimination in a ventilator assisted breath.
Time frame: 30 minutes
1 secondary outcome
Blood CO2 concentration.
Time frame: 30 minutes
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 14 May 2015.
- Derived from this study: PubMed 27440637Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.
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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.
Mikael Bodelsson, Professor principal investigator
Division of Anesthesia, Skane University Hospital, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altered breath in people with Pulmonary Gas Exchange and Carbon Dioxide, run by Region Skane at 1 site in Sweden.
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 1 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 14 May 2015. 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 Sweden. 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?
Carbon dioxide elimination in a ventilator assisted breath. (time frame: 30 minutes). 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 NCT01686984, which also lists 1 linked publication.
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 14 May 2015.