Predictors of Respiratory Failure Following Extubation in the SICU

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01967056
• Other study ID #: 2012P001783
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: October 17, 2013
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: Ulrich Schmidt, M.D
• Phone: 617-643-4408
• Email: uschmidt[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Renal Failure
• Respiratory Comorbidities
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bittner EA, Schmidt UH. Tracheal reintubation: caused by "too much of a good thing"? Respir Care. 2012 Oct;57(10):1687-91. — View Citation

Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c. — View Citation

Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe. — View Citation

Walcher A, Faubel S, Keniston A, Dennen P. In critically ill patients requiring CRRT, AKI is associated with increased respiratory failure and death versus ESRD. Ren Fail. 2011;33(10):935-42. doi: 10.3109/0886022X.2011.615964. Epub 2011 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Failure	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)	30 days	No
Secondary	Reintubation within 72 hours	The investigators will follow patients and observe whether they require reintubation within 72 h	72 hours	No
Secondary	Non-invasive ventilation for treatment of extubation failure	The investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure	72 hours	No
Secondary	Tracheostomy		Patients will be followed for 30 days of hospitalization	No
Secondary	SICU length of stay		180 days	No
Secondary	Hospital length of stay		180 days	No