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

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: Respiratory Insufficiency
• Intervention / Treatment: Other: Invasive method; Other: Non invasive method

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics	2 hours

Collaborators and Investigators

• 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

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: Respiratory Insufficiency [C08.618.846]
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ERNI-0073496