AgingNCT00097630
ABC Trial: Awakening and Breathing Controlled
A study testing SAT: Spontaneous Awakening Trial and SBT: Spontaneous Breathing Trial in people with Aging and Respiration, Artificial, run by National Institute on Aging (NIA) at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging, Respiration, Artificial
- What is being tested?
- SAT: Spontaneous Awakening Trial and SBT: Spontaneous Breathing Trial
- Type of treatment
- Surgery or procedure
- How many people
- 334 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2003to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago
Chicago, Illinois, 60637
St. Thomas Hospital
Nashville, Tennessee, 37202
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pennsylvania - Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cognitive Impairment in the ICU: Evaluation and Outcomes
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).
Read the 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).
- Conditions
- Aging, Respiration, Artificial
- Being tested
- SAT: Spontaneous Awakening Trial, SBT: Spontaneous Breathing Trial
- Keywords
- mechanical ventilation, delirium, sedation scoring, cognitive impairment, ventilation weaning
- Medical subject headings
- Respiratory Aspiration, Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT: Spontaneous Awakening TrialProcedure or surgery
SBT: Spontaneous Breathing TrialProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Secondary outcomes (7)
Length of stay in the ICU and hospital
28-day and 1-year survival
Duration of coma and delirium
Cognitive function
Measured: at discharge, 3 months, and 12 months
Psychological status
Measured: at discharge, 3 months, and 12 months
Functional status
Measured: at discharge, 3 months, and 12 months
Quality of life
Measured: at discharge, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study startOct 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 334 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- St. Thomas Foundation, Tennessee, Vanderbilt University
- Investigators
- E Wesley Ely, MD, MPH, Principal investigator, Vanderbilt University Medical CenterBrenda T Pun, RN, ACNP, Study director, Vanderbilt University Medical CenterRichard W Light, MD, Principal investigator, St. Thomas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097630
- Sponsor's protocol ID
- AG0011
- Other IDs
- 5K23AG001023-04
- Status last verified
- Aug 2008
- First submitted
- 24 Nov 2004
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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. doi: 10.1056/NEJM199612193352502.
PubMed 8948561Kress 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. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Girard 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 paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PubMed 18191684Jackson JC, Girard TD, Gordon SM, Thompson JL, Shintani AK, Thomason JW, Pun BT, Canonico AE, Dunn JG, Bernard GR, Dittus RS, Ely EW. Long-term cognitive and psychological outcomes in the awakening and breathing controlled trial. Am J Respir Crit Care Med. 2010 Jul 15;182(2):183-91. doi: 10.1164/rccm.200903-0442OC. Epub 2010 Mar 18.
PubMed 20299535
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in the ICU: Evaluation and Outcomes
- ClinicalTrials.gov ID
- NCT00097630
- Acronym / sponsor ID
- AG0011
- Conditions
- Aging, Respiration, Artificial
- Keywords
- mechanical ventilation, delirium, sedation scoring, cognitive impairment, ventilation weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- St. Thomas Foundation, Tennessee, Vanderbilt University
- Study start
- Oct 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 25 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAT: Spontaneous Awakening Trial | Procedure or surgery | – |
| SBT: Spontaneous Breathing Trial | Procedure or surgery | – |
Primary outcome
Ventilator free days
7 secondary outcomes
Length of stay in the ICU and hospital
28-day and 1-year survival
Duration of coma and delirium
Cognitive function
Time frame: at discharge, 3 months, and 12 months
Psychological status
Time frame: at discharge, 3 months, and 12 months
Functional status
Time frame: at discharge, 3 months, and 12 months
Quality of life
Time frame: at discharge, 3 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 8948561Ely 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. doi: 10.1056/NEJM199612193352502.
- Background: PubMed 10816184Kress 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. doi: 10.1056/NEJM200005183422002.
- Results publication: PubMed 18191684Girard 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 paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Derived from this study: PubMed 20299535Jackson JC, Girard TD, Gordon SM, Thompson JL, Shintani AK, Thomason JW, Pun BT, Canonico AE, Dunn JG, Bernard GR, Dittus RS, Ely EW. Long-term cognitive and psychological outcomes in the awakening and breathing controlled trial. Am J Respir Crit Care Med. 2010 Jul 15;182(2):183-91. doi: 10.1164/rccm.200903-0442OC. Epub 2010 Mar 18.
- Focus on delirium and other issues associated with ICU patients.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAT: Spontaneous Awakening Trial and SBT: Spontaneous Breathing Trial in people with Aging and Respiration, Artificial, run by National Institute on Aging (NIA) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097630, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.