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Completed

NCT Number: NCT02816359

Position and Esophageal Pressure

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Croix-Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

head-bed position

Other

Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes

Primary outcomes

  1. 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° )

Secondary outcomes

  1. End-inspiratory esophageal pressure

    Time frame: 30min after change of position

    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° )

  2. Gastric pressure

    Time frame: 30min after change of position

    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° )

  3. End-expiratory lung volume

    Time frame: 30min after change of position

    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° )

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: pEsition

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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