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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Automatic Tube Compensation plus CPAP
Continuous Positive Airway Pressure
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring INDIRECT CALORIMETRY, MECHANICAL VENTILATION, WEANING VENTILATOR, AUTOMATIC TUBE COMPENSATION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Automatic tube compensation plus CPAP

Continuous Positive Airway Pressure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measurement of oxygen consumption through indirect calorimetry.
Measurements using indirect calorimetry for determination of oxygen consumption

Secondary Outcome Measures

Measurement of energy expenditure through indirect calorimetry
Measurement using indirect calorimetry for determination of energy expenditure.

Full Information

First Posted
December 17, 2012
Last Updated
November 25, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01757093
Brief Title
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.
Official Title
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
INDIRECT CALORIMETRY, MECHANICAL VENTILATION, WEANING VENTILATOR, AUTOMATIC TUBE COMPENSATION

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic tube compensation plus CPAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automatic Tube Compensation plus CPAP
Other Intervention Name(s)
ATC+CPAP
Intervention Description
SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
SPONTANEOUS BREATHING TRIAL WITH CPAP
Primary Outcome Measure Information:
Title
Measurement of oxygen consumption through indirect calorimetry.
Description
Measurements using indirect calorimetry for determination of oxygen consumption
Time Frame
The measurement is during the spontaneous breathing trial, 30 minutes.
Secondary Outcome Measure Information:
Title
Measurement of energy expenditure through indirect calorimetry
Description
Measurement using indirect calorimetry for determination of energy expenditure.
Time Frame
The measurement is during the spontaneous breathing trial, 30 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Fa Lago, physiotherap
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049900
Country
Brazil

12. IPD Sharing Statement

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

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