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

November 25, 2014 updated by: Alessandra Fabiane Lago, University of Sao Paulo

Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ATC+CPAP
Device: Continuous Positive Airway Pressure
SPONTANEOUS BREATHING TRIAL WITH CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The measurement is during the spontaneous breathing trial, 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The measurement is during the spontaneous breathing trial, 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Alessandra Fa Lago, physiotherap, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFL-0705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Failure

Clinical Trials on Automatic Tube Compensation plus CPAP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe