Clinical trial NCT02416037: Trans-pulmonary Pressure in ARDS
Official title: Trans-Pulmonary Pressure and Prone Position in Ards Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
prone position
PEEP
mechanical ventilation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Value of the esophageal pressure measured at the end of expiration
timeFrame: 6.5 hours after inclusion
measure: Value of the esophageal pressure measured at the end of expiration
timeFrame: 8.0 hours after inclusion
measure: Value of the esophageal pressure measured at the end of expiration
timeFrame: 10 hours after inclusion
measure: Value of the esophageal pressure measured at the end of expiration
timeFrame: 11.5 hours after inclusion
measure: Value of the esophageal pressure measured at the end of expiration
timeFrame: up to 26.5 hours after inclusion
Secondary outcomes:
measure: Elastance of the chest wall
timeFrame: 6.5 hours after inclusion
measure: Elastance of the chest wall
timeFrame: 8.0 hours after inclusion
measure: Elastance of the chest wall
timeFrame: 10 hours after inclusion
measure: Elastance of the chest wall
timeFrame: 11.5 hours after inclusion
measure: Elastance of the chest wall
timeFrame: up to 26.5 hours after inclusion
measure: Transpulmonary pressure at the end of expiration (Ptp,ee)
timeFrame: 6.5 hours after inclusion
measure: Transpulmonary pressure at the end of expiration (Ptp,ee)
timeFrame: 8.0 hours after inclusion
measure: Transpulmonary pressure at the end of expiration (Ptp,ee)
timeFrame: 10 hours after inclusion
measure: Transpulmonary pressure at the end of expiration (Ptp,ee)
timeFrame: 11.5 hours after inclusion
measure: Transpulmonary pressure at the end of expiration (Ptp,ee)
timeFrame: up to 26.5 hours after inclusion
measure: End expiratory lung volume (EELV)
timeFrame: 6.5 hours after inclusion
measure: End expiratory lung volume (EELV)
timeFrame: 8.0 hours after inclusion
measure: End expiratory lung volume (EELV)
timeFrame: 10 hours after inclusion
measure: End expiratory lung volume (EELV)
timeFrame: 11.5 hours after inclusion
measure: End expiratory lung volume (EELV)
timeFrame: up to 26.5 hours after inclusion
measure: Regional lung ventilation
timeFrame: 6.5 hours after inclusion
measure: Regional lung ventilation
timeFrame: 8.0 hours after inclusion
measure: Regional lung ventilation
timeFrame: 10 hours after inclusion
measure: Regional lung ventilation
timeFrame: 11.5 hours after inclusion
measure: Regional lung ventilation
timeFrame: up to 26.5 hours after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
References: