Position and Esophageal Pressure (pEsition)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: head-bed position

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hôpital Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Subject deprived of freedom, minor, subject under a legal protective measure
• Research team unavailability
• Lack of medical care plan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: head-bed position; Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes	Other: head-bed position; Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total End-expiratory esophageal pressure	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° )	30min after change of position

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-inspiratory esophageal pressure	After end-inspiratory 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° )	30min after change of position
Gastric pressure	After end-expiratory pause and end-inspiratory pause on the ventilator, absolute value of the gastric pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )	30min after change of position
End-expiratory lung volume	End-expiratory lung volume is measured with nitrogen wash-in wash-out method, available in the ventilator (in Head-bed position at 30° then in head-bed position at 0° )	30min after change of position

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claude Guerin, Pr, Hospices civils de Lyon

Publications and helpful links

General Publications

• Mezidi M, Guerin C. Effect of body position and inclination in supine and prone position on respiratory mechanics in acute respiratory distress syndrome. Intensive Care Med. 2019 Feb;45(2):292-294. doi: 10.1007/s00134-018-5493-1. Epub 2018 Dec 7. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal pressure; Position patient
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: 69HCL16_0152