Acute Respiratory Distress SyndromeT3PNCT02416037
Trans-pulmonary Pressure in ARDS
A study testing level of positive end expiratory pressure (Prone Proseva) and level of positive end expiratory pressure (Prone Talmor) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- level of positive end expiratory pressure (Prone Proseva) and level of positive end expiratory pressure (Prone Talmor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2016to 13 Apr 2017
- 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
- ARDS
- intubated
- indication of proning
- no contra-indication of proning
Who cannot join
- contra-indication to proning
- contra-indication to esophageal balloon
- proning before
- end of life decision
- legal protection
- pregnancy
- ECMO
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital de la Croix Rousse
Lyon, 69004
Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Official title: Trans-Pulmonary Pressure and Prone Position in Ards Patients
Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.
The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- level of positive end expiratory pressure (Prone Proseva), level of positive end expiratory pressure (Prone Talmor)
- Keywords
- ARDS, prone position, PEEP, mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of positive end expiratory pressure (Prone Proseva)Device
PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure
level of positive end expiratory pressure (Prone Talmor)Device
PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure
| Study group | Role | What they receive |
|---|---|---|
| Prone Proseva | Experimental | Not described Receives: Device: level of positive end expiratory pressure (Prone Proseva) |
| Prone Talmor | Active comparator | Not described Receives: Device: level of positive end expiratory pressure (Prone Talmor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the esophageal pressure measured at the end of expiration
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Measured: 6.5 hours after inclusion
Value of the esophageal pressure measured at the end of expiration
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Measured: 8.0 hours after inclusion
Value of the esophageal pressure measured at the end of expiration
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Measured: 10 hours after inclusion
Value of the esophageal pressure measured at the end of expiration
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Measured: 11.5 hours after inclusion
Value of the esophageal pressure measured at the end of expiration
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Measured: up to 26.5 hours after inclusion
Secondary outcomes (20)
Elastance of the chest wall
The elastance of the chest wall is the change in esophageal pressure between expiration and inspiration in response to a change in lung volume. It is not substantially changed by PEEP but it is by the change in position.
Measured: 6.5 hours after inclusion
Elastance of the chest wall
The elastance of the chest wall is the change in esophageal pressure between expiration and inspiration in response to a change in lung volume. It is not substantially changed by PEEP but it is by the change in position.
Measured: 8.0 hours after inclusion
Elastance of the chest wall
The elastance of the chest wall is the change in esophageal pressure between expiration and inspiration in response to a change in lung volume. It is not substantially changed by PEEP but it is by the change in position.
Measured: 10 hours after inclusion
Elastance of the chest wall
The elastance of the chest wall is the change in esophageal pressure between expiration and inspiration in response to a change in lung volume. It is not substantially changed by PEEP but it is by the change in position.
Measured: 11.5 hours after inclusion
Elastance of the chest wall
The elastance of the chest wall is the change in esophageal pressure between expiration and inspiration in response to a change in lung volume. It is not substantially changed by PEEP but it is by the change in position.
Measured: up to 26.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
In the standardized condition, either in supine or prone, the transpulmonary pressure is the difference between airway pressure and esophageal pressure at the end of expiration. In the standardized approach, PEEP is set according to a PEEP/FIO2 table and Ptp,ee is dependent on the PEEP/FIO2 table. With the Talmor approach, Ptp,ee is directly set from measurement of esophageal pressure and PEEP set according to the PEEP/FIO2 table.
Measured: 6.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
In the standardized condition, either in supine or prone, the transpulmonary pressure is the difference between airway pressure and esophageal pressure at the end of expiration. In the standardized approach, PEEP is set according to a PEEP/FIO2 table and Ptp,ee is dependent on the PEEP/FIO2 table. With the Talmor approach, Ptp,ee is directly set from measurement of esophageal pressure and PEEP set according to the PEEP/FIO2 table.
Measured: 8.0 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
In the standardized condition, either in supine or prone, the transpulmonary pressure is the difference between airway pressure and esophageal pressure at the end of expiration. In the standardized approach, PEEP is set according to a PEEP/FIO2 table and Ptp,ee is dependent on the PEEP/FIO2 table. With the Talmor approach, Ptp,ee is directly set from measurement of esophageal pressure and PEEP set according to the PEEP/FIO2 table.
Measured: 10 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
In the standardized condition, either in supine or prone, the transpulmonary pressure is the difference between airway pressure and esophageal pressure at the end of expiration. In the standardized approach, PEEP is set according to a PEEP/FIO2 table and Ptp,ee is dependent on the PEEP/FIO2 table. With the Talmor approach, Ptp,ee is directly set from measurement of esophageal pressure and PEEP set according to the PEEP/FIO2 table.
Measured: 11.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
In the standardized condition, either in supine or prone, the transpulmonary pressure is the difference between airway pressure and esophageal pressure at the end of expiration. In the standardized approach, PEEP is set according to a PEEP/FIO2 table and Ptp,ee is dependent on the PEEP/FIO2 table. With the Talmor approach, Ptp,ee is directly set from measurement of esophageal pressure and PEEP set according to the PEEP/FIO2 table.
Measured: up to 26.5 hours after inclusion
End expiratory lung volume (EELV)
EELV is the volume of gas at the end of expiration. It is measured from the ventilator by using the washout-washin technique after a small change in the FIO2. An increase in EELV can indicate recruitment (reopening of non aerated lung tissue) but some overinflation may also contribute to this increase. PEEP and prone position can increase EELV.
Measured: 6.5 hours after inclusion
End expiratory lung volume (EELV)
EELV is the volume of gas at the end of expiration. It is measured from the ventilator by using the washout-washin technique after a small change in the FIO2. An increase in EELV can indicate recruitment (reopening of non aerated lung tissue) but some overinflation may also contribute to this increase. PEEP and prone position can increase EELV.
Measured: 8.0 hours after inclusion
End expiratory lung volume (EELV)
EELV is the volume of gas at the end of expiration. It is measured from the ventilator by using the washout-washin technique after a small change in the FIO2. An increase in EELV can indicate recruitment (reopening of non aerated lung tissue) but some overinflation may also contribute to this increase. PEEP and prone position can increase EELV.
Measured: 10 hours after inclusion
End expiratory lung volume (EELV)
EELV is the volume of gas at the end of expiration. It is measured from the ventilator by using the washout-washin technique after a small change in the FIO2. An increase in EELV can indicate recruitment (reopening of non aerated lung tissue) but some overinflation may also contribute to this increase. PEEP and prone position can increase EELV.
Measured: 11.5 hours after inclusion
End expiratory lung volume (EELV)
EELV is the volume of gas at the end of expiration. It is measured from the ventilator by using the washout-washin technique after a small change in the FIO2. An increase in EELV can indicate recruitment (reopening of non aerated lung tissue) but some overinflation may also contribute to this increase. PEEP and prone position can increase EELV.
Measured: up to 26.5 hours after inclusion
Regional lung ventilation
regional ventilation is measured by using electrical impedance tomography. The change in thoracic impedance in response to electric current of small amplitude (50 ms) is proportional to amount of air among other factors, which are less important in magnitude as compared to air. The lung is sampled into anterior and posterior regions. The location of better aeration with PEEP and position will be mapped.
Measured: 6.5 hours after inclusion
Regional lung ventilation
regional ventilation is measured by using electrical impedance tomography. The change in thoracic impedance in response to electric current of small amplitude (50 ms) is proportional to amount of air among other factors, which are less important in magnitude as compared to air. The lung is sampled into anterior and posterior regions. The location of better aeration with PEEP and position will be mapped.
Measured: 8.0 hours after inclusion
Regional lung ventilation
regional ventilation is measured by using electrical impedance tomography. The change in thoracic impedance in response to electric current of small amplitude (50 ms) is proportional to amount of air among other factors, which are less important in magnitude as compared to air. The lung is sampled into anterior and posterior regions. The location of better aeration with PEEP and position will be mapped.
Measured: 10 hours after inclusion
Regional lung ventilation
regional ventilation is measured by using electrical impedance tomography. The change in thoracic impedance in response to electric current of small amplitude (50 ms) is proportional to amount of air among other factors, which are less important in magnitude as compared to air. The lung is sampled into anterior and posterior regions. The location of better aeration with PEEP and position will be mapped.
Measured: 11.5 hours after inclusion
Regional lung ventilation
regional ventilation is measured by using electrical impedance tomography. The change in thoracic impedance in response to electric current of small amplitude (50 ms) is proportional to amount of air among other factors, which are less important in magnitude as compared to air. The lung is sampled into anterior and posterior regions. The location of better aeration with PEEP and position will be mapped.
Measured: up to 26.5 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJan 2016
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416037
- Sponsor's protocol ID
- 69HCL14-0333
- Acronym
- T3P
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2015
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mezidi M, Parrilla FJ, Yonis H, Riad Z, Bohm SH, Waldmann AD, Richard JC, Lissonde F, Tapponnier R, Baboi L, Mancebo J, Guerin C. Effects of positive end-expiratory pressure strategy in supine and prone position on lung and chest wall mechanics in acute respiratory distress syndrome. Ann Intensive Care. 2018 Sep 10;8(1):86. doi: 10.1186/s13613-018-0434-2.
PubMed 30203117
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Pulmonary Pressure and Prone Position in Ards Patients
- ClinicalTrials.gov ID
- NCT02416037
- Acronym / sponsor ID
- T3P / 69HCL14-0333
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, prone position, PEEP, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 14 Apr 2015 (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.
Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.
The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Proseva | Experimental | Device: level of positive end expiratory pressure (Prone Proseva) |
| Prone Talmor | Active comparator | Device: level of positive end expiratory pressure (Prone Talmor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ARDS
- intubated
- indication of proning
- no contra-indication of proning
Key exclusion criteria (7 listed)
- contra-indication to proning
- contra-indication to esophageal balloon
- proning before
- end of life decision
- legal protection
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 |
|---|---|---|
| level of positive end expiratory pressure (Prone Proseva)PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure | Device | Prone Proseva |
| level of positive end expiratory pressure (Prone Talmor)PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure | Device | Prone Talmor |
Primary outcome
Value of the esophageal pressure measured at the end of expiration
Time frame: 6.5 hours after inclusion
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Value of the esophageal pressure measured at the end of expiration
Time frame: 8.0 hours after inclusion
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Value of the esophageal pressure measured at the end of expiration
Time frame: 10 hours after inclusion
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Value of the esophageal pressure measured at the end of expiration
Time frame: 11.5 hours after inclusion
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
Value of the esophageal pressure measured at the end of expiration
Time frame: up to 26.5 hours after inclusion
Oesophageal pressure is measured from a balloon inserted into the mid oesophagus at the end of expiration. Its value is subtracted to the airway pressure at the end of expiration leading to trans-pulmonary pressure at the end of expiration (Ptp,ee). The measurements are done first in the supine position. In the standardized condition PEEP is set from a PEEP/FIO2 table and Ptp,ee is measured. In the Talmor approach PEEP is set to obtain Ptp,ee between 0 and 10 cm H2O. The patient is then turned to the prone position. The measurements are repeated in the same way. Then for the rest of the proning session the patient receive either level of PEEP from each strategy. Measurements are repeated at the end of the session.
20 secondary outcomes
Elastance of the chest wall
Time frame: 6.5 hours after inclusion
Elastance of the chest wall
Time frame: 8.0 hours after inclusion
Elastance of the chest wall
Time frame: 10 hours after inclusion
Elastance of the chest wall
Time frame: 11.5 hours after inclusion
Elastance of the chest wall
Time frame: up to 26.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
Time frame: 6.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
Time frame: 8.0 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
Time frame: 10 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
Time frame: 11.5 hours after inclusion
Transpulmonary pressure at the end of expiration (Ptp,ee)
Time frame: up to 26.5 hours after inclusion
End expiratory lung volume (EELV)
Time frame: 6.5 hours after inclusion
End expiratory lung volume (EELV)
Time frame: 8.0 hours after inclusion
End expiratory lung volume (EELV)
Time frame: 10 hours after inclusion
End expiratory lung volume (EELV)
Time frame: 11.5 hours after inclusion
End expiratory lung volume (EELV)
Time frame: up to 26.5 hours after inclusion
Regional lung ventilation
Time frame: 6.5 hours after inclusion
Regional lung ventilation
Time frame: 8.0 hours after inclusion
Regional lung ventilation
Time frame: 10 hours after inclusion
Regional lung ventilation
Time frame: 11.5 hours after inclusion
Regional lung ventilation
Time frame: up to 26.5 hours after inclusion
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 11 Sep 2025.
- Results publication: PubMed 30203117Mezidi M, Parrilla FJ, Yonis H, Riad Z, Bohm SH, Waldmann AD, Richard JC, Lissonde F, Tapponnier R, Baboi L, Mancebo J, Guerin C. Effects of positive end-expiratory pressure strategy in supine and prone position on lung and chest wall mechanics in acute respiratory distress syndrome. Ann Intensive Care. 2018 Sep 10;8(1):86. doi: 10.1186/s13613-018-0434-2.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing level of positive end expiratory pressure (Prone Proseva) and level of positive end expiratory pressure (Prone Talmor) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 2 sites 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 4 inclusion and 7 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Value of the esophageal pressure measured at the end of expiration (time frame: 6.5 hours after inclusion). The study lists 5 primary outcomes in all. 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 NCT02416037, 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 11 Sep 2025.