NCT00097630

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 11, 2009

Status Verified

August 1, 2008

Enrollment Period

3.8 years

First QC Date

November 24, 2004

Last Update Submit

December 9, 2009

Conditions

AgingRespiration, Artificial

Keywords

mechanical ventilationdeliriumsedation scoringcognitive impairmentventilation weaning

Outcome Measures

Primary Outcomes (1)

  • 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

    at discharge, 3 months, and 12 months

  • Psychological status

    at discharge, 3 months, and 12 months

  • +2 more secondary outcomes

Interventions

SAT: Spontaneous Awakening TrialPROCEDURE
SBT: Spontaneous Breathing TrialPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania - Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37202, United States

Location

Related Publications (4)

  • 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.

    PMID: 8948561BACKGROUND

  • 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. doi: 10.1056/NEJM200005183422002.

    PMID: 10816184BACKGROUND

  • 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 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.

    PMID: 18191684RESULT

  • Jackson 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.

    PMID: 20299535DERIVED

Related Links

MeSH Terms

Conditions

Respiratory AspirationDeliriumCognitive Dysfunction

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • E Wesley Ely, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Brenda T Pun, RN, ACNP

    Vanderbilt University Medical Center

    STUDY DIRECTOR

  • Richard W Light, MD

    St. Thomas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

October 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 11, 2009

Record last verified: 2008-08

Locations

US(4)