Aging, Respiration, Artificial
Conditions
Keywords
mechanical ventilation, delirium, sedation scoring, cognitive impairment, ventilation weaning
Brief 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).
Interventions
PROCEDURESAT: Spontaneous Awakening Trial
PROCEDURESBT: Spontaneous Breathing Trial
Sponsors
St. Thomas Foundation, Tennessee
Vanderbilt University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator free days | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day and 1-year survival | — |
| Duration of coma and delirium | — |
| Cognitive function | at discharge, 3 months, and 12 months |
| Length of stay in the ICU and hospital | — |
| Functional status | at discharge, 3 months, and 12 months |
| Quality of life | at discharge, 3 months, and 12 months |
| Psychological status | at discharge, 3 months, and 12 months |
Countries
United States
Outcome results
None listed