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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

Tracking Information
First Submitted Date October 16, 2013
First Posted Date October 22, 2013
Last Update Posted Date October 22, 2013
Study Start Date June 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2013)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 17, 2013)
  • Reintubation within 72 hours [ Time Frame: 72 hours ]
    The investigators will follow patients and observe whether they require reintubation within 72 h
  • 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
  • Tracheostomy [ Time Frame: Patients will be followed for 30 days of hospitalization ]
  • SICU length of stay [ Time Frame: 180 days ]
  • Hospital length of stay [ Time Frame: 180 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Respiratory Failure Following Extubation in the SICU
Official Title Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Muscle Weakness
  • Renal Failure
  • Respiratory Comorbidities
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 17, 2013)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01967056
Other Study ID Numbers 2012P001783
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ulrich Schmidt, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ulrich Schmidt, MD The Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date October 2013