Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

NCT ID: NCT02743624

Last Updated: 2017-01-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.

Detailed Description

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Use of excessive pressure support

Conditions

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Acute Mechanical Ventilatory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Pressure Support Titration

The analysis of the diagnostic accuracy of the breathing pattern variables, P 0.1 and the rate of tracheal muscle relaxation.

Group Type OTHER

Variation of the level of pressure support during the mechanical ventilation

Intervention Type PROCEDURE

The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,

Interventions

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Variation of the level of pressure support during the mechanical ventilation

The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients under invasive mechanical ventilation for 48h
* patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
* spontaneous breathing,
* clinically stability.

Exclusion Criteria

* Previous disease of the central nervous system that can lead to respiratory changes.
* Previous disease of the peripheral nervous system that can lead to respiratory changes
* Previous muscular disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Carvalho

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Hospital Clinicas Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Hearth Institute - University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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tematicomusculoUTI

Identifier Type: -

Identifier Source: org_study_id

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