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

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. Identifier: NCT01618240
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : August 27, 2013
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment
Swallowing Disorder Aspiration Long Term Ventilation Other: Muscle Strength Measurement Other: Ventilator

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining Predictors of Adequate Upper Airway Function in Long-term Ventilated Patients
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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.

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 identifier (NCT number): NCT01618240

United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Matthias Eikermann, MD, PhD MGH, Harvard Medical School

Publications of Results:
Other Publications:
Responsible Party: Matthias Eikermann, Assistant Professor, Massachusetts General Hospital Identifier: NCT01618240     History of Changes
Other Study ID Numbers: 2010P001919A
First Posted: June 13, 2012    Key Record Dates
Results First Posted: August 27, 2013
Last Update Posted: October 13, 2014
Last Verified: May 2013

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:

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