ALS and Airway Clearance (ALSAC): Is There a Best Therapy for Airway Clearance in Patients with ALS?

Donna D. Gardner, MSHP, RRT, FAARC
University of Texas Health Science Center at San Antonio

Hypotheses:

ALS patients develop progressive respiratory muscle weakness which leads to respiratory insufficiency and ineffective airway clearance control. Lung function and the ability to cough are also compromised. When patients are not able to cough effectively, the secretions are retained and lead to infections, pneumonia and atelectasis.

These conditions frequently result in emergency room visits and hospitalizations and can lead to respiratory distress and arrest. This cascade of events can potentially be diminished by the use of airway clearance devices, such as the mechanical insufflator/exsufflator (MIE) or a high frequency chest wall oscillator (HFCWO). The recent American Academy of Neurology (AAN) guidelines recommend considering MIE as potentially effective for airway clearance in ALS patients who have reduced peak cough flow. However, the AAN found insufficient evidence to support or refute the use of HFCWO. Furthermore, there are no studies evaluating the combination of these
therapies.

Each of these devices are proven to be effective for their designed purpose, however neither assists with both cough efficiency and effective airway clearance.
The broad objectives of our program are to evaluate the combined use of the MIE and HFCWO to provide full respiratory airway clearance and cough assistance among ALS patients.

Aim:

1. To evaluate the effectiveness of the MIE and HFCWO used in combination compared to each used alone
2. To compare compliance, tolerability and quality of life among the three groups.

The primary hypothesis is that MIE and HFCWO in combination will be more effective than MIE or HFCWO alone as assessed by the Patient’s Global Impression of Change in secretion removal.

Status:

Study participants will be recruited from the Health Science Center (HSC) ALS clinic, which follows approximately 200 patients. Patients will be informed of the study during routine clinic visits and given an opportunity to discuss the study, read the consent form and enroll at that time. Those who want more information before deciding will be given printed materials about the study and a copy of the consent form to take home and review. A follow-up phone call will be made two weeks later to inquire about the patient’s interest in participating in the study. We anticipate enrolling 2 – 4 patients/ month from this clinic. We will also recruit with brochures and personal contacts at the Audie Murphy VA clinic adjacent to our campus, and other ALS clinics in the San Antonio and Austin area..