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Non-invasive Measurements of Elastance and Resistance (ERNI)

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ClinicalTrials.gov Identifier: NCT01530282
Recruitment Status : Unknown
Verified February 2012 by Marco Ranieri, University of Turin, Italy.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy

Study Description
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Brief Summary:
The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Other: Invasive method Other: Non invasive method Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
Study Start Date : February 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: measurement of respiratory mechanics
Invasive method: two catheters will be inserted to measure reference respiratory mechanics Non_invasive method: airway pressure measured during a 150-200 ms occlusion at the beginning of inspiration.
 Other: Invasive method
Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)

Other: Non invasive method
Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration


Outcome Measures
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Primary Outcome Measures :
  1. Non-invasive respiratory mechanics measurement [ Time Frame: 2 hours ]
    use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • intact respiratory drive;
  • PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
  • pH between 7.35 and 7.45;
  • patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.

Exclusion Criteria:

  • infection, sepsis or septic shock; (with fever no)
  • hemodynamic instability;
  • respiratory centres depression;
  • esophageal deformity, or gastric/esophageal illnesses;
  • previous recent gastric/esophageal surgery.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530282


Contacts
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Contact: Vito Marco VM Ranieri, MD +39 0116334001 marco.ranieri@unito.it
Contact: Gabriela G Ferreyra, MSC +39 0116334001 gabriela.ferreyra@unito.it

Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Vito Marco VM RANIERI, MD Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
More Information
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Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01530282    
Other Study ID Numbers: ERNI-0073496
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by Marco Ranieri, University of Turin, Italy:
Respiratory Insufficiency [C08.618.846]
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases