Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00400881
First received: November 16, 2006
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Respiratory Failure
Other: automatic tube compensation mode of ventilation (Puritan Bennet 840 ventilator)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Duration of Weaning Time [ Time Frame: days ] [ Designated as safety issue: No ]
    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:
  • Duration of Mechanical Ventilation [ Time Frame: days ] [ Designated as safety issue: No ]
    Duration in days from day of intubation to day of extubation.


Enrollment: 122
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CPAP(continuous positive airway pressure)
CPAP (continuous positive airway pressure). This is the current standard mode for SBT in our institution. A continuous pressure of 5 cm H2O is applied with this mode. This is the control - no intervention- arm.
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 mode of ventilation (Puritan Bennet 840 ventilator)
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.
Other Name: Automatic Tube Compensation Mode, mode of ventilation of the mechanical ventilator: Puritan Bennet 840

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00400881

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

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00400881     History of Changes
Other Study ID Numbers: E06040
Study First Received: November 16, 2006
Results First Received: August 18, 2011
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
mechanical ventilation
weaning
respiratory failure
spontaneous breathing trial

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014