The Use of Airway Clearance Devices in ALS
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2016 |
| End Date: | December 2018 |
| Contact: | Dana Fine |
| Email: | dana.fine@cshs.org |
| Phone: | 310-423-1791 |
Utilization of Pulmonary Clearance Devices in Amyotrophic Lateral Sclerosis
The investigator is examining the use of one airway clearance medical device compared to the
use of two airway clearance medical devices together in patients with amyotrophic lateral
sclerosis (ALS). More specifically, the investigator wants to know how effective the use of
either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use
of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together
to maintain a healthy airway and clear secretions.
The first device is a passive form of mechanical High Frequency Chest Compression (HFCC),
which was designed to help clear the airway of mucus and other secretions through mechanical
knocking of the chest area. The second device, called a Cough Assist, aids patients to clear
mucus and secretions that they would otherwise be unable to clear with coughing. This study
will enroll up to 20 people in total at CSMC.
use of two airway clearance medical devices together in patients with amyotrophic lateral
sclerosis (ALS). More specifically, the investigator wants to know how effective the use of
either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use
of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together
to maintain a healthy airway and clear secretions.
The first device is a passive form of mechanical High Frequency Chest Compression (HFCC),
which was designed to help clear the airway of mucus and other secretions through mechanical
knocking of the chest area. The second device, called a Cough Assist, aids patients to clear
mucus and secretions that they would otherwise be unable to clear with coughing. This study
will enroll up to 20 people in total at CSMC.
This 180 day (25.7 weeks) pilot study is designed to evaluate the effectiveness of airway
clearance devices in adults with ALS. Subjects will be randomized in a 1:1 ratio to one of
two treatment groups: treatment with a mechanical HCFF device alone or treatment with both a
mechanical HFCC device and a cough assist device.
This outpatient study includes a screening/baseline visit followed by a 180 day (25.7 weeks)
treatment period with three scheduled clinic visits (day 30, day 90, day 180). Pulmonary
assessments and ALS outcome measures will be collected at each visit in addition to quality
of life assessments and device usage diaries.
clearance devices in adults with ALS. Subjects will be randomized in a 1:1 ratio to one of
two treatment groups: treatment with a mechanical HCFF device alone or treatment with both a
mechanical HFCC device and a cough assist device.
This outpatient study includes a screening/baseline visit followed by a 180 day (25.7 weeks)
treatment period with three scheduled clinic visits (day 30, day 90, day 180). Pulmonary
assessments and ALS outcome measures will be collected at each visit in addition to quality
of life assessments and device usage diaries.
Inclusion Criteria:
1. Suspected, possible, probable, Probable (Lab-Supported), or Definite ALS according to
El Escorial Criteria
2. Males and females age 18 and above
3. Novel to airway clearance device use
4. Forced vital capacity ≤ 75% of predicted
Exclusion Criteria:
1. Any contraindication for pulmonary ventilation scan including allergy to radioisotopes
2. Any contraindication for use of a pulmonary clearance device
- Susceptibility to pneumothorax
- Recent (within 30 days) barotrauma
- Unstable head or neck injury
- Active hemorrhage with hemodynamic instability
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-1791
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials
