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Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients

This study is currently recruiting participants.
Verified June 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01618240
First received: June 6, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

The investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated, tracheostomized patients. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale [NRS: 0-4] of > 1) and entering the materials into airway (PAS scale [1-8]> 1), which should predispose to endotracheal aspiration.


Condition Intervention
Swallowing Disorder
Aspiration
Long Term Ventilation
 Other: Muscle Strength Measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Muscle Strength [ Time Frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow ] [ Designated as safety issue: Yes ]
    We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.


Secondary Outcome Measures:
  • Number of patients with muscle weakness (MRC<48) who developed clinical aspiration [ Time Frame: Within 3 month follow-up ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Muscle Strength Measurement Other: Muscle Strength Measurement
MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Long term ventilated and tracheostomized patients in the Respiratory Acute and Surgical Intensive Care Unit

Criteria

Inclusion Criteria:

  1. Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital.
  2. Age over 18 years.
  3. Long-term ventilated patients (>10 days) with tracheotomies.

Exclusion Criteria:

  1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
  2. Non-cooperative patient, CAM score positive for delirium.
  3. For women: pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618240

Locations
United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Matthias Eikermann, MD, PhD     617-643-4408     MEIKERMANN@PARTNERS.ORG    
Principal Investigator: Matthias Eikermann, MD, PhD            
Sub-Investigator: Hooman Mirzakhani, MD            
Sub-Investigator: Emer Kelly, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD MGH, Harvard Medical School
  More Information

Publications:

Responsible Party: Matthias Eikermann, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01618240     History of Changes
Other Study ID Numbers: 2010P001919
Study First Received: June 6, 2012
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
FEES
PAS
VPSR
MRC

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013