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

NCT ID: NCT02945917

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Magni Federico

OTHER

Sponsor Role lead

Responsible Party

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Magni Federico

UOC Anestesia e Rianimazione ASST Monza

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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UOC Anestesia e Rianimazione

Monza, Monza E Brianza, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Magni

Role: CONTACT

Phone: +390392332127

Email: [email protected]

Facility Contacts

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Federico Magni, MD

Role: primary

Other Identifiers

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PES

Identifier Type: -

Identifier Source: org_study_id