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

Completed

• Conditions: Aspiration; Swallowing Disorder; Long Term Ventilation
• Interventions: Other: Muscle Strength Measurement; Other: Ventilator

• 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

Arm && Interventions

Group	Intervention	Description
Long term ventilated subjects	Ventilator	Muscle Strength Measurement, ventilator
Long term ventilated subjects	Muscle Strength Measurement	Muscle Strength Measurement, ventilator

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