CClinicalTrials.gg
CompletedNCT01757093Updated Dec 2, 2014

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

An interventional study of Automatic Tube Compensation plus CPAP and Continuous Positive Airway Pressure in Respiratory Failure, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Respiratory Failure

Keywords

  • INDIRECT CALORIMETRY
  • MECHANICAL VENTILATION
  • WEANING VENTILATOR
  • AUTOMATIC TUBE COMPENSATION
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 40 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • 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 · Device: Continuous Positive Airway Pressure

  • 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 · Device: Continuous Positive Airway Pressure

Interventions

  • DeviceAutomatic Tube Compensation plus CPAP

    SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP

    Also known as: ATC+CPAP

  • DeviceContinuous Positive Airway Pressure

    SPONTANEOUS BREATHING TRIAL WITH CPAP

06

What researchers measure

Primary outcomes

  1. Measurement of oxygen consumption through indirect calorimetry.

    Measurements using indirect calorimetry for determination of oxygen consumption

    Time frame: The measurement is during the spontaneous breathing trial, 30 minutes.

Secondary outcomes

  1. Measurement of energy expenditure through indirect calorimetry

    Measurement using indirect calorimetry for determination of energy expenditure.

    Time frame: The measurement is during the spontaneous breathing trial, 30 minutes.

07

Study locations

1 site
  • Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo
    Ribeirão Preto, São Paulo 14049900, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01757093
Lead sponsor
University of Sao Paulo
Responsible party
Alessandra Fabiane Lago (ALESSANDRA FABIANE LAGO, University of Sao Paulo) — Principal investigator
First posted
Dec 28, 2012
Start date
Jun 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Dec 2, 2014

Study contacts

Alessandra Fa Lago, physiotherap
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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