ABC Trial: Awakening and Breathing Controlled

This study has been completed.
Sponsor:
Collaborators:
St. Thomas Foundation, Tennessee
Vanderbilt University
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00097630
First received: November 24, 2004
Last updated: December 9, 2009
Last verified: August 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Cognitive Impairment in the ICU: Evaluation and Outcomes

Resource links provided by NLM:


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 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 ]

Estimated Enrollment: 334
Study Start Date: October 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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 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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00097630     History of Changes
Other Study ID Numbers: AG0011, 5K23AG001023-04
Study First Received: November 24, 2004
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 01, 2014