Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT01967056

Conditions

Muscle Weakness

Renal Failure

Respiratory Comorbidities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Muscle Weakness

Renal Failure

Respiratory Comorbidities

Study ID

NCT01967056

Start date

Jun, 2013

Status verified date

Oct, 2013

Completion date

Oct, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Respiratory Failure [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Ulrich Schmidt, M.D

617-643-4408uschmidt@partners.org

Jessica Hines

617-726-2859jhines1@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ulrich Schmidt, MD

617-643-4408uschmidt@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 22, 2013

Last verified

Oct, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2013-10-22.