NCT01967056

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 16, 2013

Last Update Submit

October 17, 2013

Conditions

Muscle WeaknessRenal FailureRespiratory Comorbidities

Keywords

Muscle strengthrespiratory failureextubation failureintensive care unitoutcome prediction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Reintubation within 72 hours

    72 hours

  • Non-invasive ventilation for treatment of extubation failure

    72 hours

  • Tracheostomy

    Patients will be followed for 30 days of hospitalization

  • SICU length of stay

    180 days

  • Hospital length of stay

    180 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of patients used for this study will be those admitted to the Surgical Intensive Care Unit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23571640BACKGROUND

  • 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.

    PMID: 23584384BACKGROUND

  • 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.

    PMID: 21910664BACKGROUND

  • 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.

    PMID: 23013905BACKGROUND

  • 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.

    PMID: 29096229DERIVED

  • 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.

    PMID: 26556899DERIVED

MeSH Terms

Conditions

Muscle WeaknessRenal InsufficiencyRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Ulrich Schmidt, MD

    The Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Schmidt, M.D

CONTACT

617-643-4408uschmidt@partners.org

Jessica Hines

CONTACT

617-726-2859jhines1@partners.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 22, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(1)