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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945917
• Other study ID #: PES
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: October 25, 2016
• Start date: April 2015

Study information

• Verified date: October 2016
• Source: San Gerardo Hospital
• Contact: Federico Magni
• Phone: +390392332127
• Email: magnifederico[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ARDS

Locations

Country	Name	City	State
Italy	UOC Anestesia e Rianimazione	Monza	Monza e Brianza

Sponsors (1)

Lead Sponsor	Collaborator
Magni Federico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transpulmonary pressure measured estimating pleural pressure through the esophageal balloon		within 10 minutes after esophageal balloon volume changing	No
Secondary	End-expiratory lung volume		within 60 minutes after PEEP changing	No