Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 University of Turin, Italy.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy Identifier:
First received: February 6, 2012
Last updated: February 8, 2012
Last verified: February 2012
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:

Further study details as provided by 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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01530282

Contact: Vito Marco VM Ranieri, MD +39 0116334001
Contact: Gabriela G Ferreyra, MSC +39 0116334001

Sponsors and Collaborators
University of Turin, Italy
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 Identifier: NCT01530282     History of Changes
Other Study ID Numbers: ERNI-0073496
Study First Received: February 6, 2012
Last Updated: February 8, 2012

Keywords provided by 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 processed this record on April 28, 2017