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Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.

NCT ID: NCT01757093

Last Updated: 2014-12-02

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to compare the oxygen consumption and energy expenditure during the spontaneous breathing trial.

Detailed Description

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Patients is going to submit to the 2 spontaneous breathing trial ( Automatic tube compensation plus continuous positive airway pressure and continuous positive airway pressure without automatic tube compensation. The oxygen consumption and energy expenditure is going to measure during the spontaneous breathing trial by indirect calorimetry.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Automatic tube compensation plus CPAP

The patients is going to undergo trials of spontaneous breathing with automatic tube compensation plus continuous positive airway pressure and later a trial with continuous positive airway pressure. During 30 minutes.

Group Type EXPERIMENTAL

Automatic Tube Compensation plus CPAP

Intervention Type DEVICE

SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP

Continuous Positive Airway Pressure

Intervention Type DEVICE

SPONTANEOUS BREATHING TRIAL WITH CPAP

Continuous Positive Airway Pressure

The patients is going to undergo a trial of spontaneous breathing with continuous positive airway pressure and later with automatic tube compensation plus continuous positive airway pressure, during 30 minutes each.

Group Type ACTIVE_COMPARATOR

Automatic Tube Compensation plus CPAP

Intervention Type DEVICE

SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP

Continuous Positive Airway Pressure

Intervention Type DEVICE

SPONTANEOUS BREATHING TRIAL WITH CPAP

Interventions

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Automatic Tube Compensation plus CPAP

SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP

Intervention Type DEVICE

Continuous Positive Airway Pressure

SPONTANEOUS BREATHING TRIAL WITH CPAP

Intervention Type DEVICE

Other Intervention Names

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ATC+CPAP

Eligibility Criteria

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Inclusion Criteria

* IMPROVEMENT OR RESOLUTION OF THE UNDERLYING CAUSE OF DISEASE
* INTUBATED PATIENTS\>24h
* PaO2 GREATER THAN 60 mmHg WITH FiO2 LESS THAN 40%
* PEEP=5 cmH2O

Exclusion Criteria

* CARDIOVASCULAR INSTABILITY
* FEBRILE OR HYPOTHERMIA
* CHEST DRAINAGE
* RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105
* PREGNANCY
* FAIL IN THE SPONTANEOUS BREATHING TRIAL
* LEAKS IN THE CIRCUIT
* AGITATION
* NOT ACCEPT PARTICIPATE IN THE STUDY
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Fabiane Lago

ALESSANDRA FABIANE LAGO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Fa Lago, physiotherap

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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AFL-0705

Identifier Type: -

Identifier Source: org_study_id