Respiratory FailureNCT01757093
Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial.
A study testing Automatic Tube Compensation plus CPAP and Continuous Positive Airway Pressure in people with Respiratory Failure, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the oxygen consumption and energy expenditure during the spontaneous breathing trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Automatic Tube Compensation plus CPAP and Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CARDIOVASCULAR INSTABILITY
- FEBRILE OR HYPOTHERMIA
- CHEST DRAINAGE
- RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105
- PREGNANCY
- FAIL IN THE SPONTANEOUS BREATHING TRIAL
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- LEAKS IN THE CIRCUIT
- AGITATION
- NOT ACCEPT PARTICIPATE IN THE STUDY
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049900
About this study
Official title: 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.
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.
- Conditions
- Respiratory Failure
- Being tested
- Automatic Tube Compensation plus CPAP, Continuous Positive Airway Pressure
- Keywords
- INDIRECT CALORIMETRY, MECHANICAL VENTILATION, WEANING VENTILATOR, AUTOMATIC TUBE COMPENSATION
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Tube Compensation plus CPAPDevice
Also called ATC+CPAP
SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
Continuous Positive Airway PressureDevice
SPONTANEOUS BREATHING TRIAL WITH CPAP
| Study group | Role | What they receive |
|---|---|---|
| Automatic tube compensation plus CPAP | Experimental | 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. Receives: Device: Automatic Tube Compensation plus CPAP; Device: Continuous Positive Airway Pressure |
| Continuous Positive Airway Pressure | Active comparator | 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. Receives: Device: Automatic Tube Compensation plus CPAP; Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxygen consumption through indirect calorimetry.
Measurements using indirect calorimetry for determination of oxygen consumption
Measured: 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.
Measured: The measurement is during the spontaneous breathing trial, 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Fabiane Lago, University of Sao Paulo
- Investigators
- Alessandra Fa Lago, physiotherap, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757093
- Sponsor's protocol ID
- AFL-0705
- Status last verified
- Nov 2014
- First submitted
- 17 Dec 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Consumption and Energy Expenditure During Spontaneous Breathing Trial - A Randomized Crossover Controled Trial.
- ClinicalTrials.gov ID
- NCT01757093
- Acronym / sponsor ID
- AFL-0705
- Conditions
- Respiratory Failure
- Keywords
- INDIRECT CALORIMETRY, MECHANICAL VENTILATION, WEANING VENTILATOR, AUTOMATIC TUBE COMPENSATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic tube compensation plus CPAP | Experimental | Device: Automatic Tube Compensation plus CPAP, Device: Continuous Positive Airway PressureThe 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. |
| Continuous Positive Airway Pressure | Active comparator | Device: Automatic Tube Compensation plus CPAP, Device: Continuous Positive Airway PressureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- CARDIOVASCULAR INSTABILITY
- FEBRILE OR HYPOTHERMIA
- CHEST DRAINAGE
- RESPIRATORY RATE/TIDAL VOLUME RATIO GREATER THAN 105
- PREGNANCY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Tube Compensation plus CPAPAlso: ATC+CPAPSPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP | Device | Automatic tube compensation plus CPAP, Continuous Positive Airway Pressure |
| Continuous Positive Airway PressureSPONTANEOUS BREATHING TRIAL WITH CPAP | Device | Automatic tube compensation plus CPAP, Continuous Positive Airway Pressure |
Primary outcome
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
1 secondary outcome
Measurement of energy expenditure through indirect calorimetry
Time frame: The measurement is during the spontaneous breathing trial, 30 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Fa Lago, physiotherap principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Tube Compensation plus CPAP and Continuous Positive Airway Pressure in people with Respiratory Failure, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oxygen consumption through indirect calorimetry. (time frame: The measurement is during the spontaneous breathing trial, 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.