NCT00097630

ABC Trial: Awakening and Breathing Controlled

Cognitive Impairment in the ICU: Evaluation and Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (planned)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Aging
• Respiration, Artificial

Interventions

Type	Name	Description
PROCEDURE	SAT: Spontaneous Awakening Trial
PROCEDURE	SBT: Spontaneous Breathing Trial

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2004-11-25
• Last updated: 2009-12-11

Locations

4 sites across 1 country: United States