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Non-invasive Measurements of Elastance and Resistance (ERNI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Marco Ranieri, University of Turin, Italy.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530282
First Posted: February 9, 2012
Last Update Posted: February 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
  Purpose
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 Intervention Phase
Respiratory Insufficiency Other: Invasive method Other: Non invasive method Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marco Ranieri, University of Turin, Italy:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
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
Principal Investigator: Vito Marco VM RANIERI, MD Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
  More Information

Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01530282     History of Changes
Other Study ID Numbers: ERNI-0073496
First Submitted: February 6, 2012
First Posted: February 9, 2012
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:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases