Outcome Comparisons of Vibratory Airway Clearance Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-12-01

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.

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Detailed Description

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This pilot study is a randomized control trial of adult patients admitted to an academic medical center. 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. 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 or currently receiving cough assist, vest or intrapulmonary percussive ventilation. Patients receiving more than one therapy session using the oscillatory index device before enrollment will be excluded. Patients with multiple ICU admissions will be enrolled once. 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).

Conditions

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Airway Clearance Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Oscillatory Index Device

Patients in this arm will receive a device that vibrates with high oscillatory index.

Group Type EXPERIMENTAL

High Oscillatory Index Device

Intervention Type DEVICE

This device is commonly used to provide assistance with airway secretion clearance.

Low Oscillatory Index Device

Patients in this arm will receive a device that vibrates with low oscillatory index.

Group Type ACTIVE_COMPARATOR

Low Oscillatory Index Device

Intervention Type DEVICE

This device is commonly used to provide assistance with airway secretion clearance.

Interventions

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High Oscillatory Index Device

This device is commonly used to provide assistance with airway secretion clearance.

Intervention Type DEVICE

Low Oscillatory Index Device

This device is commonly used to provide assistance with airway secretion clearance.

Intervention Type DEVICE

Other Intervention Names

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Aerobika VibraPEP

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years or older
* Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5

Exclusion Criteria

* Younger than 18 years of age
* Pregnant
* Slow vital capacity (SVC) of \<10 mL/kg
* Unable to follow instructions
* Currently receiving cough assist, vest therapy or intrapulmonary percussive ventilation
* Received more than 1 therapy session using oscillatory index device
* Multiple ICU admission with previous study enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No