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

Arm | Intervention/treatment |
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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.
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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 |
- 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

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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 |
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.

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
Contact: Vito Marco VM Ranieri, MD | +39 0116334001 | marco.ranieri@unito.it | |
Contact: Gabriela G Ferreyra, MSC | +39 0116334001 | gabriela.ferreyra@unito.it |
Principal Investigator: | Vito Marco VM RANIERI, MD | Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy |
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 |
Respiratory Insufficiency [C08.618.846] |
Respiratory Insufficiency Pulmonary Valve Insufficiency Respiration Disorders Respiratory Tract Diseases |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |