Position and Esophageal Pressure

Acute Respiratory Distress Syndrome Clinical Trial

— pEsition  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816359
• Other study ID #: 69HCL16_0152
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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° )	30min after change of position
Secondary	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° )	30min after change of position
Secondary	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° )	30min after change of position
Secondary	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° )	30min after change of position