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

Further Study Details: 

Primary Outcomes: Ventilator free days
Secondary Outcomes: Length of stay in the ICU
Expected Total Enrollment:  334

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

E Wesley Ely, MD, MPH      615-936-3702    wes.ely@vanderbilt.edu
Brenda T Pun, RN, ACNP      615-936-3702    brenda.truman@vanderbilt.edu

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

Study chairs or principal investigators

E Wesley Ely, MD, MPH,  Principal Investigator,  Vanderbilt University Medical Center   
Brenda T Pun, RN, ACNP,  Study Director,  Vanderbilt University Medical Center   
Richard W Light, MD,  Principal Investigator,  St. Thomas Hospital   

Study ID Numbers:  AG0011; 5K23AG001023-04
Record last reviewed:  December 2004
Last Updated:  March 3, 2005
Record first received:  November 24, 2004
ClinicalTrials.gov Identifier:  NCT00097630
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08