Non-invasive Measurements of Elastance and Resistance (ERNI)

February 8, 2012 updated by: Marco Ranieri, University of Turin, Italy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Vito Marco VM Ranieri, MD, Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERNI-0073496

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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