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ABC Trial: Awakening and Breathing Controlled

This study has been completed.

Sponsors and Collaborators: National Institute on Aging (NIA)
St. Thomas Foundation, Tennessee
Vanderbilt University
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00097630
  Purpose

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).


Condition Intervention
Aging
Respiration, Artificial
Procedure: SAT: Spontaneous Awakening Trial
Procedure: SBT: Spontaneous Breathing Trial

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Cognitive Impairment in the ICU: Evaluation and Outcomes

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Ventilator free days

Secondary Outcome Measures:
  • Length of stay in the ICU

Estimated Enrollment:   334
Study Start Date:   October 2003
Study Completion Date:   August 2007

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097630

Locations
United States, Illinois
University of Chicago    
      Chicago, Illinois, United States, 60637
United States, Pennsylvania
Hospital of the University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania - Presbyterian Medical Center    
      Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Thomas Hospital    
      Nashville, Tennessee, United States, 37202

Sponsors and Collaborators
National Institute on Aging (NIA)
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    
  More Information

Focus on delirium and other issues associated with ICU patients.  This link exits the ClinicalTrials.gov site
 

Publications:

Publications indexed to this study:

Study ID Numbers:   AG0011, 5K23AG001023-04
First Received:   November 24, 2004
Last Updated:   September 24, 2007
ClinicalTrials.gov Identifier:   NCT00097630
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
mechanical ventilation  
delirium  
sedation scoring  
cognitive impairment  
ventilation weaning  

Study placed in the following topic categories:
Delirium

ClinicalTrials.gov processed this record on May 08, 2008