NCT02816359CompletedNot Applicable
Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Total End-expiratory esophageal pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
head-bed position
Other
Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
Intervention: head-bed position (Other)
Outcomes
Primary Outcomes
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
- End-expiratory lung volume(30min after change of position)
- End-inspiratory esophageal pressure(30min after change of position)
- Gastric pressure(30min after change of position)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
Effect of Position and Pneumoperitoneum on Respiratory Mechanics and Transpulmonary Pressure During Laparoscopic SurgeryMechanical Ventilation ComplicationNCT03526003Rambam Health Care Campus20
Completed
Not Applicable
Pediatric Diaphragm Thickness TrialChildNCT04882553University Hospital, Antwerp16
Completed
Not Applicable
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill ChildrenMechanical VentilationNCT02762279St. Justine's Hospital12
Withdrawn
Not Applicable
Comparison of Esophageal Manometry and CT Scan MeasurementsMorbid ObesityRespiratory FailureNCT04213911Massachusetts General Hospital12
Terminated
Not Applicable
Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal BalloonObesity, MorbidVentilator-Induced Lung InjuryRespiratory FailureNCT03951064University of North Carolina, Chapel Hill6