ABC Trial: Awakening and Breathing Controlled

Study Overview
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Brief Summary
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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
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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).

Official Title
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Cognitive Impairment in the ICU: Evaluation and Outcomes

Conditions
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Aging, Respiration, Artificial

Intervention / Treatment
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* Procedure: SAT: Spontaneous Awakening Trial
* Procedure: SBT: Spontaneous Breathing Trial


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SAT: Spontaneous Awakening Trial|nan|
|Procedure: SBT: Spontaneous Breathing Trial|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the ICU and hospital |  |  | 
| 28-day and 1-year survival |  |  | 
| Duration of coma and delirium |  |  | 
| Cognitive function |  | at discharge, 3 months, and 12 months | 
| Psychological status |  | at discharge, 3 months, and 12 months | 
| Functional status |  | at discharge, 3 months, and 12 months | 
| Quality of life |  | at discharge, 3 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, delirium, sedation scoring, cognitive impairment, ventilation weaning