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Trans-pulmonary Pressure in ARDS

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Respiratory Distress Syndrome

Intervention: level of positive end expiratory pressure (Prone Proseva) (Device); level of positive end expiratory pressure (Prone Talmor) (Device)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Hospices Civils de Lyon

Overall contact:
Claude GUERIN, MD, Phone: 426109418, Ext: +33, Email: claude.guerin@chu-lyon.fr

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.

Clinical Details

Official title: Trans-Pulmonary Pressure and Prone Position in Ards Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Value of the esophageal pressure measured at the end of expiration

Value of the esophageal pressure measured at the end of expiration

Value of the esophageal pressure measured at the end of expiration

Value of the esophageal pressure measured at the end of expiration

Value of the esophageal pressure measured at the end of expiration

Secondary outcome:

Elastance of the chest wall

Elastance of the chest wall

Elastance of the chest wall

Elastance of the chest wall

Elastance of the chest wall

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

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

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

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

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

End expiratory lung volume (EELV)

End expiratory lung volume (EELV)

End expiratory lung volume (EELV)

End expiratory lung volume (EELV)

End expiratory lung volume (EELV)

Regional lung ventilation

Regional lung ventilation

Regional lung ventilation

Regional lung ventilation

Regional lung ventilation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Claude GUERIN, MD, Phone: 426109418, Ext: +33, Email: claude.guerin@chu-lyon.fr

Hôpital de la Croix-Rousse, Lyon 69004, France; Not yet recruiting
Claude GUERIN, MD, Phone: 426109418, Ext: +33, Email: claude.guerin@chu-lyon.fr
Loredana BABOI, Phone: 426109265, Ext: +33, Email: loredana.baboi@chu-lyon.fr
Claude GUERIN, MD, Principal Investigator
Jean-Christophe RICHARD, MD, Sub-Investigator
Additional Information

Starting date: April 2015
Last updated: April 13, 2015

Page last updated: August 23, 2015

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