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Position and Esophageal Pressure (pEsition)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
head-bed position
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome focused on measuring Position patient, Esophageal pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Croix-Rousse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

head-bed position

Arm Description

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

Outcomes

Primary Outcome Measures

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° )

Secondary Outcome Measures

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° )
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° )
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° )

Full Information

First Posted
June 24, 2016
Last Updated
January 18, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02816359
Brief Title
Position and Esophageal Pressure
Acronym
pEsition
Official Title
Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Position patient, Esophageal pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
head-bed position
Arm Type
Other
Arm Description
Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
Intervention Type
Other
Intervention Name(s)
head-bed position
Intervention Description
Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
Primary Outcome Measure Information:
Title
Total End-expiratory esophageal pressure
Description
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° )
Time Frame
30min after change of position
Secondary Outcome Measure Information:
Title
End-inspiratory esophageal pressure
Description
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° )
Time Frame
30min after change of position
Title
Gastric pressure
Description
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° )
Time Frame
30min after change of position
Title
End-expiratory lung volume
Description
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° )
Time Frame
30min after change of position

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Guerin, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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Position and Esophageal Pressure

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