Trans-pulmonary Pressure in ARDS

NCT02416037 | Completed

• 1 other identifier: 69HCL14-0333
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

ARDS; prone position; PEEP; mechanical ventilation

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  up to 26.5 hours after inclusion

Secondary Outcomes (20)

• Elastance of the chest wall

  6.5 hours after inclusion

• Elastance of the chest wall

  8.0 hours after inclusion

• Elastance of the chest wall

  10 hours after inclusion

• Elastance of the chest wall

  11.5 hours after inclusion

• Elastance of the chest wall

  up to 26.5 hours after inclusion

Study Arms (2)

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)

Interventions

level of positive end expiratory pressure (Prone Proseva) DEVICE

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Prone Proseva

level of positive end expiratory pressure (Prone Talmor) DEVICE

PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure

Prone Talmor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

• 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.

  PMID: 30203117 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 14, 2015
• Study Start: January 1, 2016
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (2)