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

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ClinicalTrials.gov Identifier: NCT01757093
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Alessandra Fabiane Lago, University of Sao Paulo

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

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Automatic Tube Compensation plus CPAP Device: Continuous Positive Airway Pressure Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Device: Automatic Tube Compensation plus CPAP
SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
Other Name: ATC+CPAP
Device: Continuous Positive Airway Pressure
SPONTANEOUS BREATHING TRIAL WITH CPAP
Active Comparator: 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.
Device: Automatic Tube Compensation plus CPAP
SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
Other Name: ATC+CPAP
Device: Continuous Positive Airway Pressure
SPONTANEOUS BREATHING TRIAL WITH CPAP



Primary Outcome Measures :
  1. Measurement of oxygen consumption through indirect calorimetry. [ Time Frame: The measurement is during the spontaneous breathing trial, 30 minutes. ]
    Measurements using indirect calorimetry for determination of oxygen consumption


Secondary Outcome Measures :
  1. Measurement of energy expenditure through indirect calorimetry [ Time Frame: The measurement is during the spontaneous breathing trial, 30 minutes. ]
    Measurement using indirect calorimetry for determination of energy expenditure.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757093


Locations
Brazil
Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Alessandra Fa Lago, physiotherap University of Sao Paulo

Responsible Party: Alessandra Fabiane Lago, ALESSANDRA FABIANE LAGO, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01757093     History of Changes
Other Study ID Numbers: AFL-0705
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Alessandra Fabiane Lago, University of Sao Paulo:
INDIRECT CALORIMETRY
MECHANICAL VENTILATION
WEANING VENTILATOR
AUTOMATIC TUBE COMPENSATION

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases