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| 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 |
| 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 |
| Estimated Enrollment: | 334 |
| Study Start Date: | October 2003 |
| Study Completion Date: | August 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| 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 |
More Information
Focus on delirium and other issues associated with ICU patients. 
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| 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 |
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