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Predictors of Respiratory Failure Following Extubation in the SICU

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ClinicalTrials.gov Identifier: NCT01967056
Recruitment Status : Unknown
Verified October 2013 by Ulrich Schmidt, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
Ulrich Schmidt, Massachusetts General Hospital

Brief Summary:
Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.

Condition or disease
Muscle Weakness Renal Failure Respiratory Comorbidities

Detailed Description:

Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.

Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.

In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.

Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.


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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)
Study Start Date : June 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Respiratory Failure [ Time Frame: 30 days ]
    The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)


Secondary Outcome Measures :
  1. Reintubation within 72 hours [ Time Frame: 72 hours ]
    The investigators will follow patients and observe whether they require reintubation within 72 h

  2. Non-invasive ventilation for treatment of extubation failure [ Time Frame: 72 hours ]
    The investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure

  3. Tracheostomy [ Time Frame: Patients will be followed for 30 days of hospitalization ]
  4. SICU length of stay [ Time Frame: 180 days ]
  5. Hospital length of stay [ Time Frame: 180 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population of patients used for this study will be those admitted to the Surgical Intensive Care Unit
Criteria

Inclusion Criteria:

  • Adults (18 years of age or greater)
  • Patients who have been extubated following mechanical ventilation in the surgical ICU

Exclusion Criteria:

  • Preexisting end-stage renal disease
  • Neurological disorder associated with severe muscle weakness
  • Goals of care focused on comfort

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967056


Contacts
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Contact: Ulrich Schmidt, M.D 617-643-4408 uschmidt@partners.org
Contact: Jessica Hines 617-726-2859 jhines1@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ulrich Schmidt, MD    617-643-4408    uschmidt@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ulrich Schmidt, MD The Massachusetts General Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulrich Schmidt, Associate Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01967056     History of Changes
Other Study ID Numbers: 2012P001783
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013
Keywords provided by Ulrich Schmidt, Massachusetts General Hospital:
Muscle strength
respiratory failure
extubation failure
intensive care unit
outcome prediction
Additional relevant MeSH terms:
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Muscle Weakness
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms