Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

Respiratory Failure Clinical Trial

Official title:

Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400881
• Other study ID #: E06040
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2006
• Last updated: October 29, 2015
• Start date: January 2007
• Est. completion date: January 2011

Study information

• Verified date: October 2015
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University Medical Center Hospital	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Weaning Time	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.	days	No
Secondary	Duration of Mechanical Ventilation	Duration in days from day of intubation to day of extubation.	days	No