Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400881
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : May 17, 2012
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
Juan B. Figueroa-Casas, Texas Tech University Health Sciences Center, El Paso

Brief Summary:
To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: automatic tube compensation Not Applicable

Detailed Description:

The ultimate goal of this proposal is to find the best way to rapidly and safely discontinue mechanical ventilation in patients recovering from respiratory failure.

It is common practice in these patients to perform trials of "spontaneous" breathing while still connected to the ventilator in order to assess their readiness to breathe without assistance. To help with this assessment, new mechanical modes have been incorporated to modern ventilators. A recently developed mode, called Automatic Tube Compensation, is designed for this purpose ("spontaneous" breathing). Whether this method is superior to traditional ones has not been established and the investigators intend to address this question.

The investigators aim to:

  1. compare Automatic Tube Compensation vs. our traditional mode (Continuous Positive Airway Pressure) during spontaneous breathing trials in their efficacy to identify patients ready be successfully removed from mechanical ventilation
  2. study which physiologic variables better predict successful discontinuation of mechanical ventilation in these two modes.

The investigators plan to prospectively randomize patients on mechanical ventilation at the point of weaning evaluation, to undergo spontaneous breathing trials with our current ventilatory mode (Continuous Positive Airway Pressure) or the new mode (Automatic Tube Compensation). Based on predefined physiologic and clinical variables, clinicians will decide whether patients are ready to be removed from mechanical ventilation. The proportions of successful discontinuation (no need to reinstitute mechanical ventilation) and the duration of the weaning period in both groups will be compared. During the spontaneous breathing trials, respiratory variables will be measured and compared between patients with successful vs. non successful discontinuation in order to evaluate their predictive value for successful outcome.

Mechanical ventilation is being used increasingly given our growing population with advanced age and multiple co morbidities and the rising volume of aggressive medical procedures. It is well known to be associated with medical complications and high health care costs. Reducing the duration of unnecessary mechanical ventilation while minimizing the risk of premature removal of needed assistance is the final objective of this project. Approaching this goal will decrease the adverse effects of this treatment and the cost of critical care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Study Start Date : January 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
No Intervention: Continuous PAP (CPAP)
CPAP (continuous positive airway pressure). 5 cm H2O.
Experimental: Automatic tube compensation (ATC)
ATC is a new mode of ventilation being compared with traditional one (CPAP). ATC is a mode of ventilation of the same device (mechanical ventilator), not a new device. The pressure in this modes varies according the mechanical parameters of the respiratory system that are automatically calculated by this mode. This is the intervention arm.
Other: automatic tube compensation
new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.

Primary Outcome Measures :
  1. Duration of Weaning Time [ Time Frame: days ]
    Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.

Secondary Outcome Measures :
  1. Duration of Mechanical Ventilation [ Time Frame: days ]
    Duration in days from day of intubation to day of extubation.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients 18 years of age or older
  • on mechanical ventilation at Thomason Hospital Intensive Care Unit for more than 24 hours
  • about to undergo SBT by the current institutional protocol for weaning assessment ordered by their treating physician
  • availability of informed consent from patient or next of kin

Exclusion Criteria:

  • patients for whom a decision has been made not to reinstitute ventilatory assistance under any circumstance
  • pregnancy
  • patients not considered for discontinuation of mechanical ventilation on the day of SBT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400881

United States, Texas
University Medical Center Hospital
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Principal Investigator: Juan B Figueroa-Casas, MD Assistant Professor, Texas Tech University HSC

Responsible Party: Juan B. Figueroa-Casas, Associate Professor, Texas Tech University Health Sciences Center, El Paso Identifier: NCT00400881     History of Changes
Other Study ID Numbers: E06040
First Posted: November 17, 2006    Key Record Dates
Results First Posted: May 17, 2012
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Juan B. Figueroa-Casas, Texas Tech University Health Sciences Center, El Paso:
mechanical ventilation
respiratory failure
spontaneous breathing trial

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes