Position and Esophageal Pressure

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: head-bed position

• Registration Number: NCT02816359
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total End-expiratory esophageal pressure	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 Outcome Measures

Name	Time	Method
End-inspiratory esophageal pressure	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° )
Gastric pressure	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° )
End-expiratory lung volume	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° )

Trial Locations

Locations (1)

Hôpital Croix-Rousse; 🇫🇷 Lyon, France