Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.

Hospices Civils de Lyon1 site in 1 country11 target enrollmentMay 1, 2016

ConditionsAcute Respiratory Distress Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Hospices Civils de Lyon
Enrollment: 11
Locations: 1
Primary Endpoint: Total End-expiratory esophageal pressure
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.

Registry

clinicaltrials.gov

Start Date

May 1, 2016

End Date

September 1, 2017

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Acute respiratory failure defined by PaO2/FIO2\< 300 mmHg or pH\<7,35 and pCO2\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:
•New or worsening respiratory symptoms in the previous week.
•Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules
•Respiratory failure not fully explained by cardiac failure or fluid overload
•PaO2/FIO2\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight
•Patient intubated or tracheotomized and receiving mechanical ventilation
•Indication of esophageal measurement decided by the clinician

Exclusion Criteria

•Contraindication to naso-gastric tube insertion :
•Recent gastro-duodenal ulcer
•Stage III esophageal varices
•Refractory intracranial hypertension
•Unstabilized spine fracture
•Surgical contraindication
•Burns on more than 20 % of the body surface
•Underlying disease with a life expectancy of less than one year
•End-of-life decision before inclusion
•Pregnant or breast-feeding patients

Outcomes

Primary Outcomes

Total End-expiratory esophageal pressure

Time Frame: 30min after change of position

After end-expiratory pause on the ventilator, absolute value of the esophageal pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )