Swallowing Disorder, Aspiration, Long Term Ventilation
Conditions
Keywords
FEES, PAS, VPSR, MRC
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.
Interventions
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
OTHERVentilator
A mechanical ventilator is used to assist or replace spontaneous breathing.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration | Within 3 month follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Population Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Baseline Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Muscle Strength
We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.
Time frame: Within 24 hours of fiberoptic endoscopic evaluation of swallow
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Muscle Strength Measurement | Muscle Strength | Clinically significant muscle weakness (<48) | 20 participants |
| Muscle Strength Measurement | Muscle Strength | No clinically significant muscle weakness (>=48) | 10 participants |
Secondary
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration
Time frame: Within 3 month follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Muscle Strength Measurement | Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration | Symptomatic aspiration | 14 participants |
| Muscle Strength Measurement | Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration | No symptomatic aspiration | 6 participants |