Non-invasive Measurements of Elastance and Resistance
ERNI
Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
1 other identifier
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2012
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 9, 2012
February 1, 2012
9 months
February 6, 2012
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-invasive respiratory mechanics measurement
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
2 hours
Study Arms (1)
measurement of respiratory mechanics
EXPERIMENTALInvasive 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.
Interventions
Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)
Non\_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- infection, sepsis or septic shock; (with fever no)
- hemodynamic instability;
- respiratory centres depression;
- esophageal deformity, or gastric/esophageal illnesses;
- previous recent gastric/esophageal surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vito Marco VM RANIERI, MD
Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Professor
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 9, 2012
Study Start
February 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 9, 2012
Record last verified: 2012-02