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Predictors of Respiratory Failure Following Extubation in the SICU

Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01967056
Enrollment
750
Registered
2013-10-22
Start date
2013-06-30
Completion date
2014-10-31
Last updated
2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness, Renal Failure, Respiratory Comorbidities

Keywords

Muscle strength, respiratory failure, extubation failure, intensive care unit, outcome prediction

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Failure30 daysThe 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

MeasureTime frameDescription
Reintubation within 72 hours72 hoursThe investigators will follow patients and observe whether they require reintubation within 72 h
Non-invasive ventilation for treatment of extubation failure72 hoursThe investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure
TracheostomyPatients will be followed for 30 days of hospitalization
SICU length of stay180 days
Hospital length of stay180 days

Countries

United States

Contacts

Primary ContactUlrich Schmidt, M.D
uschmidt@partners.org617-643-4408
Backup ContactJessica Hines
jhines1@partners.org617-726-2859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026