Skip to main content
OpenTrials
Completed

NCT Number: NCT02416037

Trans-pulmonary Pressure in ARDS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ARDS
  • intubated
  • indication of proning
  • no contra-indication of proning

Exclusion criteria

  • contra-indication to proning
  • contra-indication to esophageal balloon
  • proning before
  • end of life decision
  • legal protection
  • pregnancy
  • ECMO

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Elastance of the chest wall

    Time frame: 6.5 hours after inclusion

    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.

  2. Elastance of the chest wall

    Time frame: 8.0 hours after inclusion

    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.

  3. Elastance of the chest wall

    Time frame: 10 hours after inclusion

    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.

  4. Elastance of the chest wall

    Time frame: 11.5 hours after inclusion

    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.

  5. Elastance of the chest wall

    Time frame: up to 26.5 hours after inclusion

    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.

  6. Transpulmonary pressure at the end of expiration (Ptp,ee)

    Time frame: 6.5 hours after inclusion

    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.

  7. Transpulmonary pressure at the end of expiration (Ptp,ee)

    Time frame: 8.0 hours after inclusion

    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.

  8. Transpulmonary pressure at the end of expiration (Ptp,ee)

    Time frame: 10 hours after inclusion

    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.

  9. Transpulmonary pressure at the end of expiration (Ptp,ee)

    Time frame: 11.5 hours after inclusion

    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.

  10. Transpulmonary pressure at the end of expiration (Ptp,ee)

    Time frame: up to 26.5 hours after inclusion

    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.

  11. End expiratory lung volume (EELV)

    Time frame: 6.5 hours after inclusion

    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.

  12. End expiratory lung volume (EELV)

    Time frame: 8.0 hours after inclusion

    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.

  13. End expiratory lung volume (EELV)

    Time frame: 10 hours after inclusion

    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.

  14. End expiratory lung volume (EELV)

    Time frame: 11.5 hours after inclusion

    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.

  15. End expiratory lung volume (EELV)

    Time frame: up to 26.5 hours after inclusion

    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.

  16. Regional lung ventilation

    Time frame: 6.5 hours after inclusion

    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.

  17. Regional lung ventilation

    Time frame: 8.0 hours after inclusion

    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.

  18. Regional lung ventilation

    Time frame: 10 hours after inclusion

    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.

  19. Regional lung ventilation

    Time frame: 11.5 hours after inclusion

    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.

  20. Regional lung ventilation

    Time frame: up to 26.5 hours after inclusion

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Trans-Pulmonary Pressure and Prone Position in Ards Patients

Acronym: T3P

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.