Back to resultsNon-invasive Measurements of Elastance and Resistance (ERNI)
Primary Purpose
Respiratory Insufficiency
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Invasive method
Non invasive method
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency [C08.618.846]
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
measurement of respiratory mechanics
Arm Description
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.
Outcomes
Primary Outcome Measures
Non-invasive respiratory mechanics measurement
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
Secondary Outcome Measures
Full Information
NCT ID
NCT01530282
First Posted
February 6, 2012
Last Updated
February 8, 2012
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01530282
Brief Title
Non-invasive Measurements of Elastance and Resistance
Acronym
ERNI
Official Title
Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory Insufficiency [C08.618.846]
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
measurement of respiratory mechanics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Invasive method
Intervention Description
Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)
Intervention Type
Other
Intervention Name(s)
Non invasive method
Intervention Description
Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration
Primary Outcome Measure Information:
Title
Non-invasive respiratory mechanics measurement
Description
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vito Marco VM Ranieri, MD
Phone
+39 0116334001
Email
marco.ranieri@unito.it
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela G Ferreyra, MSC
Phone
+39 0116334001
Email
gabriela.ferreyra@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vito Marco VM RANIERI, MD
Organizational Affiliation
Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Measurements of Elastance and Resistance
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