Trial Outcomes & Findings for Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients (NCT NCT01618240)

Results Overview

We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Within 24 hours of fiberoptic endoscopic evaluation of swallow

Results posted on

2014-10-13

Participant milestones
Measure	Long-term Ventilated Subjects Long-term (\>10 days hours) ventilated subjects were included.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Baseline Population n=30 Participants Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	Muscle Strength Measurement n=30 Participants Muscle Strength Measurement : 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
Muscle Strength Clinically significant muscle weakness (<48)	20 participants
Muscle Strength No clinically significant muscle weakness (>=48)	10 participants

Timeframe: Within 3 month follow-up

Outcome measures
Measure	Muscle Strength Measurement n=20 Participants Muscle Strength Measurement : 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
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration Symptomatic aspiration	14 participants
Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration No symptomatic aspiration	6 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Massachusetts General Hospital

Phone: 617-291-9779