ABC Trial: Awakening and Breathing Controlled

Aging Clinical Trial

Official title:

Cognitive Impairment in the ICU: Evaluation and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097630
• Other study ID #: AG0011
• Secondary ID: 5K23AG001023-04
• Status: Completed
• Phase: N/A
• First received: November 24, 2004
• Last updated: December 9, 2009
• Start date: October 2003
• Est. completion date: August 2007

Study information

• Verified date: August 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Respiration, Artificial

Intervention

Procedure:
• SAT: Spontaneous Awakening Trial

• SBT: Spontaneous Breathing Trial

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania - Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	St. Thomas Foundation, Tennessee, Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. — View Citation

Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a pair — View Citation

Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days
Secondary	Length of stay in the ICU and hospital
Secondary	28-day and 1-year survival
Secondary	Duration of coma and delirium
Secondary	Cognitive function		at discharge, 3 months, and 12 months
Secondary	Psychological status		at discharge, 3 months, and 12 months
Secondary	Functional status		at discharge, 3 months, and 12 months
Secondary	Quality of life		at discharge, 3 months, and 12 months

External Links

•   Focus on delirium and other issues associated with ICU patients.