Non-invasive Measurements of Elastance and Resistance

NCT ID: NCT01530282

Last Updated: 2012-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Invasive method

Intervention Type OTHER

Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)

Non invasive method

Intervention Type OTHER

Non\_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration

Interventions

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Invasive method

Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)

Intervention Type OTHER

Non invasive method

Non\_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Marco Ranieri

MD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vito Marco VM RANIERI, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Central Contacts

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Vito Marco VM Ranieri, MD

Role: CONTACT

+39 0116334001

Gabriela G Ferreyra, MSC

Role: CONTACT

+39 0116334001

Other Identifiers

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ERNI-0073496

Identifier Type: -

Identifier Source: org_study_id

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