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Position and Esophageal Pressure (pEsition)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Acute Respiratory Distress Syndrome

Treatments

Other: head-bed position

Study type

Interventional

Funder types

Other

Identifiers

NCT02816359
69HCL16_0152

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

head-bed position
Other group
Description:
Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
Treatment:
Other: head-bed position

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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