Clinical trial NCT00400881: Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Official title: Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: mechanical ventilation
weaning
respiratory failure
spontaneous breathing trial
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Duration of Weaning Time
timeFrame: days
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: days
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University Medical Center Hospital
state: Texas
Study officials:
affiliation: Assistant Professor, Texas Tech University HSC
name: Juan B Figueroa-Casas, MD
role: PRINCIPAL_INVESTIGATOR
References: