ABC Trial: Awakening and Breathing Controlled

Not Applicable

Completed

• Conditions: Aging; Respiration, Artificial

• Registration Number: NCT00097630
• Lead Sponsor: National Institute on Aging (NIA)

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).

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2004-11-24
• Study First Submitted QC: 2004-11-24
• Study First Posted: 2004-11-25
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-08
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilator free days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

St. Thomas Hospital; 🇺🇸 Nashville, Tennessee, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Pennsylvania - Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States