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

Completed

Conditions studied: Swallowing Disorder, Aspiration, Long Term Ventilation

In brief

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.

Key facts

Study ID

NCT01618240

Run by

Massachusetts General Hospital

People needed

30

Starts

2011-01-01

Expected to finish

2012-04-01

Last updated by the study team

2014-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age over 18 years.
• Long-term ventilated patients (>10 days) with tracheotomies

You may not qualify if…

• Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
• Non-cooperative patient, CAM score positive for delirium.
• For women: pregnancy.

Where it is running

• Massachusetts general Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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