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

NCT01757093 | Completed DMC

• 1 other identifier: AFL-0705
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Failure

Keywords

INDIRECT CALORIMETRY; MECHANICAL VENTILATION; WEANING VENTILATOR; AUTOMATIC TUBE COMPENSATION

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Measurement of energy expenditure through indirect calorimetry

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

Study Arms (2)

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.

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.

Device: Automatic Tube Compensation plus CPAP; Device: Continuous Positive Airway Pressure

Interventions

Automatic Tube Compensation plus CPAP DEVICE

SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP

Also known as: ATC+CPAP

Automatic tube compensation plus CPAP; Continuous Positive Airway Pressure

Continuous Positive Airway Pressure DEVICE

SPONTANEOUS BREATHING TRIAL WITH CPAP

Automatic tube compensation plus CPAP; Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Alessandra Fa Lago, physiotherap

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ALESSANDRA FABIANE LAGO

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 28, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

BR (1)