Non-invasive Measurements of Elastance and Resistance (ERNI)

University of Turin

Status and phase: Unknown; Phase 2

Conditions: Respiratory Insufficiency

Treatments: Other: Non invasive method; Other: Invasive method

Study type: Interventional

Funder types: Other

Identifiers

NCT01530282

ERNI-0073496

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

measurement of respiratory mechanics

Experimental group

Description:

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.

Treatment:

Other: Non invasive method

Other: Invasive method