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Clinical Trials/NCT02945917
NCT02945917
Unknown
Not Applicable

Positive End-expiratory Pressure and Esophageal Catheter Optimal Calibration Volume in ARDS Patients

Magni Federico1 site in 1 country16 target enrollmentApril 2015
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Magni Federico
Enrollment
16
Locations
1
Primary Endpoint
transpulmonary pressure measured estimating pleural pressure through the esophageal balloon
Last Updated
9 years ago

Overview

Brief Summary

The use of esophageal balloon catheter to estimate pleural pressure has gained renewed popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more pathophysiological-based approach to ventilator strategy in acute respiratory distress syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter derived parameters can be influenced by several patient-related or technical-related factors.

During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and derived measurements obtained using different esophageal balloon calibration volumes.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Magni Federico
Responsible Party
Sponsor Investigator
Principal Investigator

Magni Federico

UOC Anestesia e Rianimazione ASST Monza

San Gerardo Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of ARDS with a PEEP of at least 8 cmH2O
  • Fraction of inspired oxygen not higher than 80%
  • Intubated and ventilated in Volume Control Ventilation mode set by the attending physician according to clinical criteria
  • Need of continuous sedation through intravenous anesthetics and full neuromuscular blockade

Exclusion Criteria

  • Been pregnant or breastfeeding
  • Hemodynamic instability
  • Presence of tracheobronchial fistula
  • Known pneumothorax
  • Leak in airway circuitry
  • Presence of any kind of inhalator therapy (e.g. Heliox, nitric oxide, anesthetic conserving device)
  • Recent history of nasal trauma or lesion of nasal cavity
  • Recent history of esophageal, gastrointestinal, ENT, thoracic or cardiac surgery (less than 2 months)
  • Known or suspected esophageal varices
  • Congenital, acquired or drug-induced hemostatic disorder

Outcomes

Primary Outcomes

transpulmonary pressure measured estimating pleural pressure through the esophageal balloon

Time Frame: within 10 minutes after esophageal balloon volume changing

Secondary Outcomes

  • End-expiratory lung volume(within 60 minutes after PEEP changing)

Study Sites (1)

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