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Predictors of Respiratory Failure Following Extubation in the SICU

NCT ID: NCT01967056

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Muscle Weakness Renal Failure Respiratory Comorbidities

Keywords

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Muscle strength respiratory failure extubation failure intensive care unit outcome prediction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulrich Schmidt

Associate Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrich Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

The Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ulrich Schmidt, M.D

Role: CONTACT

Phone: 617-643-4408

Email: [email protected]

Jessica Hines

Role: CONTACT

Phone: 617-726-2859

Email: [email protected]

Facility Contacts

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Ulrich Schmidt, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23571640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23584384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21910664 (View on PubMed)

Bittner EA, Schmidt UH. Tracheal reintubation: caused by "too much of a good thing"? Respir Care. 2012 Oct;57(10):1687-91. doi: 10.4187/respcare.02082. No abstract available.

Reference Type BACKGROUND
PMID: 23013905 (View on PubMed)

Fuchs G, Thevathasan T, Chretien YR, Mario J, Piriyapatsom A, Schmidt U, Eikermann M, Fintelmann FJ. Lumbar skeletal muscle index derived from routine computed tomography exams predict adverse post-extubation outcomes in critically ill patients. J Crit Care. 2018 Apr;44:117-123. doi: 10.1016/j.jcrc.2017.10.033. Epub 2017 Oct 23.

Reference Type DERIVED
PMID: 29096229 (View on PubMed)

Piriyapatsom A, Williams EC, Waak K, Ladha KS, Eikermann M, Schmidt UH. Prospective Observational Study of Predictors of Re-Intubation Following Extubation in the Surgical ICU. Respir Care. 2016 Mar;61(3):306-15. doi: 10.4187/respcare.04269. Epub 2015 Nov 10.

Reference Type DERIVED
PMID: 26556899 (View on PubMed)

Other Identifiers

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2012P001783

Identifier Type: -

Identifier Source: org_study_id