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

Completed

• Conditions: Aspiration; Swallowing Disorder; Long Term Ventilation

• Registration Number: NCT01618240
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Status Verified: 2013-05
• Results First Submitted: 2013-05-21
• Results First Submitted QC: 2013-05-21
• Results First Posted: 2013-08-27
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle Strength	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

Name	Time	Method
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration	Within 3 month follow-up

Trial Locations

Locations (1)

Massachusetts general Hospital; 🇺🇸 Boston, Massachusetts, United States