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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618240
First Posted: June 13, 2012
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
  Purpose
First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. 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 Other: Ventilator

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

Further study details as provided by Matthias Eikermann, Massachusetts General Hospital:

Primary Outcome Measures:
  • Muscle Strength [ Time Frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow ]
    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 ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Enrollment: 30
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Long term ventilated subjects
Muscle Strength Measurement, ventilator
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
Other: Ventilator
A mechanical ventilator is used to assist or replace spontaneous breathing.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618240


Locations
United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
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: 2010P001919A
First Submitted: June 6, 2012
First Posted: June 13, 2012
Results First Submitted: May 21, 2013
Results First Posted: August 27, 2013
Last Update Posted: October 13, 2014
Last Verified: May 2013

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
FEES
PAS
VPSR
MRC

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