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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alessandra Fabiane Lago, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01757093
First received: December 17, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Respiratory Failure
 Device: Automatic Tube Compensation plus CPAP
Device: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Measurement of oxygen consumption through indirect calorimetry. [ Time Frame: The measurement is during the spontaneous breathing trial, 30 minutes. ] [ Designated as safety issue: No ]
    Measurements using indirect calorimetry for determination of oxygen consumption


Secondary Outcome Measures:
  • Measurement of energy expenditure through indirect calorimetry [ Time Frame: The measurement is during the spontaneous breathing trial, 30 minutes. ] [ Designated as safety issue: No ]
    Measurement using indirect calorimetry for determination of energy expenditure.


Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • INTUBATED PATIENTS>24h
  • PaO2 GREATER THAN 60 mmHg WITH FiO2 LESS THAN 40%
  • PEEP=5 cmH2O SUPPORT PRESSURE=8 CMH2O
  • USING EVITA MECHANICAL VENTILATOR

Exclusion Criteria:

  • CARDIOVASCULAR INSTABILITY
  • AFEBRILE
  • CHEST DRAINAGE
  • RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105
  • PREGNANCY
  • FAIL IN THE SPONTANEOUS BREATHING TRIAL
  • LEAKS IN THE CIRCUIT
  • AGITATION
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 17, 2012
Last Updated: December 20, 2012
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013