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Clinical Trials/NCT01530282
NCT01530282
Unknown
Phase 2

Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study

University of Turin, Italy0 sites15 target enrollmentFebruary 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
University of Turin, Italy
Enrollment
15
Primary Endpoint
Non-invasive respiratory mechanics measurement
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
November 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Marco Ranieri

MD Professor

University of Turin, Italy

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.

Outcomes

Primary Outcomes

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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