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Non-invasive Measurements of Elastance and Resistance (ERNI)

This study is not yet open for participant recruitment.
Verified February 2012 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01530282
First received: February 6, 2012
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  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: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Non-invasive respiratory mechanics measurement [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01530282     History of Changes
Other Study ID Numbers: ERNI-0073496
Study First Received: February 6, 2012
Last Updated: February 8, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
Respiratory Insufficiency [C08.618.846]

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013