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ABC Trial: Awakening and Breathing Controlled
This study has been completed.
Study NCT00097630   Information provided by National Institute on Aging (NIA)
First Received: November 24, 2004   Last Updated: August 8, 2008   History of Changes

November 24, 2004
August 8, 2008
October 2003
 
Ventilator free days
Same as current
Complete list of historical versions of study NCT00097630 on ClinicalTrials.gov Archive Site
  • Length of stay in the ICU and hospital
  • 28-day and 1-year survival
  • Duration of coma and delirium
  • Cognitive function [ Time Frame: at discharge, 3 months, and 12 months ]
  • Psychological status [ Time Frame: at discharge, 3 months, and 12 months ]
  • Functional status [ Time Frame: at discharge, 3 months, and 12 months ]
  • Quality of life [ Time Frame: at discharge, 3 months, and 12 months ]
Length of stay in the ICU
 
ABC Trial: Awakening and Breathing Controlled
Cognitive Impairment in the ICU: Evaluation and Outcomes

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).

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 coma), and in-hospital and one-year mortality. Also, cognitive, psychological, and functional/quality of life outcomes will be measured at discharge and 3 and 12 months later.

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).

 
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
  • Aging
  • Respiration, Artificial
  • Procedure: SAT: Spontaneous Awakening Trial
  • Procedure: SBT: Spontaneous Breathing Trial
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
334
August 2007
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097630
 
AG0011, 5K23AG001023-04
National Institute on Aging (NIA)
  • St. Thomas Foundation, Tennessee
  • Vanderbilt University
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
National Institute on Aging (NIA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP