Non-invasive Measurements of Elastance and Resistance

Respiratory Insufficiency Clinical Trial

— ERNI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01530282
• Other study ID #: ERNI-0073496
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 6, 2012
• Last updated: February 8, 2012
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2012
• Source: University of Turin, Italy
• Contact: Vito Marco VM Ranieri, MD
• Phone: +39 0116334001
• Email: marco.ranieri[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• Invasive method
Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)
• Non invasive method
Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No