Prone PositionPROPOCAPNCT02816190
PROne POsition and Volumetric CAPnography
An observational study of Prone Position and Mechanical Ventilation, run by Hopital of Melun at 1 site in France.
Trial summary
Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prone Position, Mechanical Ventilation, Volumetric Capnography
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 29 Mar 2018
- 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: All prone positionned patients
Who may be able to join
- all prone positioned patients
Who cannot join
- age below 18 y, dependant patients, participation reject
Trial locations and contacts
1 site in 1 country.
About this study
Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.
- Being tested
- prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
P3Slp
Evolution of phase 3 slope of volumetric capnography in survivors vs non-survivors
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
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 Prone PositionStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Jochmans, MD, Hopital of Melun
- Investigators
- sebastien jochmans, MD, Study director, Clinical Research Unit, Melun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816190
- Sponsor's protocol ID
- PROPOCAP
- Acronym
- PROPOCAP
- Status last verified
- Mar 2018
- First submitted
- 24 Jun 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.
PubMed 32449068
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROne POsition and Volumetric CAPnography
- ClinicalTrials.gov ID
- NCT02816190
- Acronym / sponsor ID
- PROPOCAP / PROPOCAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 28 Jun 2016 (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.
Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.
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
- All prone positionned patients
Key inclusion criteria (1 listed)
- all prone positioned patients
Key exclusion criteria (1 listed)
- age below 18 y, dependant patients, participation reject
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 |
|---|---|---|
| prone position | Procedure or surgery | – |
Primary outcome
P3Slp
Time frame: 24 hours
Evolution of phase 3 slope of volumetric capnography in survivors vs non-survivors
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 30 Mar 2018.
- Derived from this study: PubMed 32449068Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.
- Individual participant dataSharing planned: Undecided
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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.
sebastien jochmans, MD study director
Clinical Research Unit, Melun Hospital
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 Prone Position and Mechanical Ventilation, run by Hopital of Melun at 1 site in France.
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 30 Mar 2018. 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 France. 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?
P3Slp (time frame: 24 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 NCT02816190, 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 30 Mar 2018.