N/A
N=30
Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients
Swallowing Disorder · Aspiration · Long Term Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT01618240 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Muscle Strength — 20; 10 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Muscle Strength Measurement (Other); Ventilator (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Strength |
20; 10 | — |
| SECONDARY Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration |
14; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01618240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.