HypoventilationNCT03853057
Positive Pressure and Gravity Affect Volumetric Capnography
A study testing body positions in people with Hypoventilation, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms. Read more about this study
- Who is it for?
- Ages 28 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoventilation
- What is being tested?
- body positions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Feb 2016to 21 Feb 2019
- 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 28 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society Anesthesia physical status I.
- Age between 25-39 years old,
- Body mass index between 23-28 kg/m2,
- Non-smokers.
Who cannot join
- Presence of pulmonary or cardiac diseases.
- Abnormal spirometry.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography
Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.
Read the detailed description
In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.
- Conditions
- Hypoventilation
- Being tested
- body positions
- Keywords
- volumetric capnography, gravity, mechanical ventilation, EIT
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body positionsOther
positive pressure ventilation at different body positions
| Study group | Role | What they receive |
|---|---|---|
| non-invasive ventilation | Experimental | Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral. Receives: Other: body positions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.
Measured: 4 hours
Secondary outcomes (1)
Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
The volunteers are breathing spontaneously with and without positive pressure support. Electrical impedance images were taken at each studied condition.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Feb 2016
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoventilationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo H Tusman, MD, Principal investigator, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853057
- Sponsor's protocol ID
- 04112014
- Status last verified
- Feb 2016
- First submitted
- 3 Mar 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
PubMed 19186406Tusman G, Scandurra A, Bohm SH, Suarez-Sipmann F, Clara F. Model fitting of volumetric capnograms improves calculations of airway dead space and slope of phase III. J Clin Monit Comput. 2009 Aug;23(4):197-206. doi: 10.1007/s10877-009-9182-z. Epub 2009 Jun 11.
PubMed 19517259
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT03853057
- Acronym / sponsor ID
- 04112014
- Conditions
- Hypoventilation
- Keywords
- volumetric capnography, gravity, mechanical ventilation, EIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 25 Feb 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.
Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.
Detailed description
In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive ventilation | Experimental | Other: body positionsNon-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral. |
Who may qualify
- Ages
- 28 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society Anesthesia physical status I.
- Age between 25-39 years old,
- Body mass index between 23-28 kg/m2,
- Non-smokers.
Key exclusion criteria (2 listed)
- Presence of pulmonary or cardiac diseases.
- Abnormal spirometry.
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 |
|---|---|---|
| body positionspositive pressure ventilation at different body positions | Other | non-invasive ventilation |
Primary outcome
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
Time frame: 4 hours
The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.
1 secondary outcome
Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
Time frame: 4 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 Feb 2019.
- Background: PubMed 19186406Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
- Background: PubMed 19517259Tusman G, Scandurra A, Bohm SH, Suarez-Sipmann F, Clara F. Model fitting of volumetric capnograms improves calculations of airway dead space and slope of phase III. J Clin Monit Comput. 2009 Aug;23(4):197-206. doi: 10.1007/s10877-009-9182-z. Epub 2009 Jun 11.
- 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.
Gerardo H Tusman, MD principal investigator
Hospital Privado de Comunidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body positions in people with Hypoventilation, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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 4 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 25 Feb 2019. 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 Argentina. 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?
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation. (time frame: 4 hours). 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 NCT03853057, which also lists 2 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 25 Feb 2019.