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Position and Esophageal Pressure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02816359
Acronym
pEsition
Enrollment
11
Registered
2016-06-28
Start date
2016-05-31
Completion date
2017-09-30
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

Position patient, Esophageal pressure

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.

Interventions

OTHERhead-bed position

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total End-expiratory esophageal pressure30min after change of positionAfter 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

MeasureTime frameDescription
End-inspiratory esophageal pressure30min after change of positionAfter 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° )
Gastric pressure30min after change of positionAfter 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° )
End-expiratory lung volume30min after change of positionEnd-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° )

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026