N/A
N=5
The Use of Airway Clearance Devices in ALS
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02682030 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Frequency Chest Compression Device (HFCC) (Device); Cough Assist (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study |
0; 0 | — |
| PRIMARY Number of Subjects With Improved Respiratory Symptoms As Shown By Lung Ventilation Scan Between Baseline and End of Study |
0; 0 | — |
| PRIMARY Number of Participants With Increased McGill Single Item Quality of Life Scale Question Between Baseline and End of Study |
0; 2 | — |
| PRIMARY Number of Participants With Improved Forced Vital Capacity (FVC) Between Baseline and End of Study |
0; 0 | — |
| PRIMARY Number of Participants With Improved Maximal Inspiratory Pressure (MIP) Between Baseline and End of Study |
0; 0 | — |
| PRIMARY Number of Participants With Improved Diffusion Capacity Between Baseline and End of Study |
0; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Suspected, possible, probable, Probable (Lab-Supported), or Definite ALS according to El Escorial Criteria
- Males and females age 18 and above
- Novel to airway clearance device use
- Forced vital capacity ≤ 75% of predicted
Exclusion Criteria
- Any contraindication for pulmonary ventilation scan including allergy to radioisotopes
- 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
Data sourced from ClinicalTrials.gov (NCT02682030). 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.