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ABC Trial: Awakening and Breathing Controlled

This study has been completed.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  ABC Trial: Awakening and Breathing Controlled
Official Title  Cognitive Impairment in the ICU: Evaluation and Outcomes
Brief Summary

The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).

Detailed Description

Unnecessary delays in removing patients from mechanical ventilation increase morbidity, mortality, and cost. According to recently published guidelines, the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously, also known as spontaneous breathing trials (SBT). While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening, the benefit of combining such a daily spontaneous awakening trial (SAT) and an SBT is not known.

This multi-center, randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial (achieved by stopping all sedatives and narcotics every morning) with a daily spontaneous breathing trial is superior to the current standard of care.

The number of days the patient is able to live off the ventilator is the primary question being studied. The secondary questions include the number of days the patient is in Intensive Care Unit (ICU) and the hospital, the complications associated with being on the ventilator (such as the duration and severity of delirium and long-term cognitive impairment), and in-hospital mortality.

In addition, the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level (i.e., RASS) and delirium (i.e. CAM-ICU).

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Ventilator free days
Secondary Outcome Measure  Length of stay in the ICU
Condition  Aging
Respiration, Artificial
Intervention  Procedure: SAT: Spontaneous Awakening Trial
Procedure: SBT: Spontaneous Breathing Trial
MEDLINE PMIDs 8948561,   10816184
Links Focus on delirium and other issues associated with ICU patients. This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  334
Start Date  October 2003
Completion Date August 2007
Eligibility Criteria 

Inclusion Criteria:

  • Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
  • Require mechanical ventilation for more than 12 hours
  • Over 18 years old
  • Under the services of medicine, cardiology, and neurology

Exclusion Criteria:

  • Admission after cardiopulmonary arrest
  • Inability to obtain informed consent
  • Existence of an extubation order at the time of the evaluation
  • Dependence upon mechanical ventilation for 2 weeks prior to enrollment
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00097630
Organization ID AG0011
Secondary IDs †† 5K23AG001023-04
Study Sponsor  National Institute on Aging (NIA)
Collaborators †† St. Thomas Foundation, Tennessee
Vanderbilt University
Investigators 
Principal Investigator:     E Wesley Ely, MD, MPH     Vanderbilt University    
Study Director:     Brenda T Pun, RN, ACNP     Vanderbilt University    
Principal Investigator:     Richard W Light, MD     St. Thomas Hospital    
Information Provided By National Institute on Aging (NIA)
Verification Date September 2007
First Received Date  November 24, 2004
Last Updated Date September 24, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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