Non-invasive Measurements of Elastance and Resistance

Phase 2

• Conditions: Respiratory Insufficiency
• Interventions: Other: Invasive method; Other: Non invasive method

• Registration Number: NCT01530282
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Last Update Submitted: 2012-02-08
• Study First Posted: 2012-02-09
• Last Update Posted: 2012-02-09
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
measurement of respiratory mechanics	Invasive method	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.
measurement of respiratory mechanics	Non invasive method	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.

Primary Outcome Measures

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