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

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.

Study Overview

• Status: Unknown
• Conditions: ARDS

• Study Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

Study Locations

• Italy
  • Monza e Brianza
    • Monza, Monza e Brianza, Italy, 20900
      • Recruiting
      • UOC Anestesia e Rianimazione
      • Contact: Federico Magni, MD; Phone Number: +390392332127; Email: magnifederico@hotmail.com
      • Principal Investigator: Nicolò Patroniti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ARDS patients undergoing volume control mechanical ventilation

Description

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
• Thrombocytopenia (less than 50000/mm3)
• Recent history of Traumatic Brain Injury or thoraco-abdominal trauma (less than 1 months)
• Rib or sternal fractures

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
transpulmonary pressure measured estimating pleural pressure through the esophageal balloon	within 10 minutes after esophageal balloon volume changing

Secondary Outcome Measures

Outcome Measure	Time Frame
End-expiratory lung volume	within 60 minutes after PEEP changing

Collaborators and Investigators

• Sponsor: Magni Federico

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PES