Outcome Comparisons of Vibratory Airway Clearance Devices

Study Overview
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Brief Summary
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This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.

Detailed Description
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This pilot study is a randomized control trial of adult patients admitted to an academic medical center from April 2023 to April 2024. Subjects included in this study must be adults 18 years or older and will receive a respiratory assessment and allocation of therapy (RAAT) score of at least 10 and a secretion score of at least 5 post extubation. Exclusion criteria include those younger than 18 years of age, those who are pregnant, with an SVC of <10mL/kg, and who cannot follow instructions. After randomization, the study team will give the device to the patient and administer instructions on the device use. Each eligible patient will receive clinical evaluation using RAAT scores per the department policy. The frequency of using oscillatory index devices will be based on the department protocol. Each subject will be followed up until discharge from the hospital. The primary outcome will be the RAAT score. The RAAT score range from 0-50 and includes five components: respiratory rate, oxygen therapy, chest x-ray, secretion clearance, and vital capacity. The higher score denotes respiratory compromise, and therapy is assigned for score 10 or greater per departmental protocol. The secondary outcomes include respiratory interventions used or other bronchial hygiene (vest therapy, intrapulmonary percussive ventilation) performed, ICU re-admission, need for continuous positive pressure, and length of stay (hospital and ICU).

Official Title
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Outcome Comparisons of Two Vibratory Positive Expiratory Pressure Devices in Patients Unable to Clear Airway Secretions

Conditions
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Airway Clearance Impairment

Intervention / Treatment
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* Device: High Oscillatory Index Device
* Device: Low Oscillatory Index Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years or older and will Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5 post extubation Exclusion Criteria: Younger than 18 years of age Pregnant Slow vital capacity (SVC) of <10 mL/kg Unable to follow instructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Oscillatory Index Device<br>Patients in this arm will receive a device that vibrates with high oscillatory index. | Device: High Oscillatory Index Device<br>* This device is commonly used to provide assistance with airway secretion clearance.<br>* Other names: Aerobika;|
| Active Comparator: Low Oscillatory Index Device<br>Patients in this arm will receive a device that vibrates with low oscillatory index. | Device: Low Oscillatory Index Device<br>* This device is commonly used to provide assistance with airway secretion clearance.<br>* Other names: VibraPEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory assess and treat (RAAT) score | The RAAT score range from 0-50. | Change from baseline RAAT score at 12 hours |