Trans-pulmonary Pressure in ARDS (T3P)

Civil Hospices of Lyon

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02416037

69HCL14-0333

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Prone Proseva

Experimental group

Treatment:

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

Prone Talmor

Active Comparator group

Treatment:

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