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Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
automatic tube compensation
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Failure focused on measuring mechanical ventilation, weaning, respiratory failure, spontaneous breathing trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Continuous PAP (CPAP)

Automatic tube compensation (ATC)

Arm Description

CPAP (continuous positive airway pressure). 5 cm H2O.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Mechanical Ventilation
Duration in days from day of intubation to day of extubation.

Full Information

First Posted
November 16, 2006
Last Updated
May 5, 2017
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT00400881
Brief Title
Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Official Title
Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
mechanical ventilation, weaning, respiratory failure, spontaneous breathing trial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous PAP (CPAP)
Arm Type
No Intervention
Arm Description
CPAP (continuous positive airway pressure). 5 cm H2O.
Arm Title
Automatic tube compensation (ATC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
automatic tube compensation
Intervention Description
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 Measure Information:
Title
Duration of Weaning Time
Description
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.
Time Frame
days
Secondary Outcome Measure Information:
Title
Duration of Mechanical Ventilation
Description
Duration in days from day of intubation to day of extubation.
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan B Figueroa-Casas, MD
Organizational Affiliation
Assistant Professor, Texas Tech University HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

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