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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757093
• Other study ID #: AFL-0705
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: November 25, 2014
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Automatic Tube Compensation plus CPAP
SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
• Continuous Positive Airway Pressure
SPONTANEOUS BREATHING TRIAL WITH CPAP

Locations

Country	Name	City	State
Brazil	Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto -Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of oxygen consumption through indirect calorimetry.	Measurements using indirect calorimetry for determination of oxygen consumption	The measurement is during the spontaneous breathing trial, 30 minutes.	No
Secondary	Measurement of energy expenditure through indirect calorimetry	Measurement using indirect calorimetry for determination of energy expenditure.	The measurement is during the spontaneous breathing trial, 30 minutes.	No