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RecruitingNCT05873504Updated Feb 19, 2026

Outcome Comparisons of Vibratory Airway Clearance Devices

An interventional study of High Oscillatory Index Device and Low Oscillatory Index Device in Airway Clearance Impairment, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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. Cluster randomization will be used, with device assignment alternating by month. The assigned device will be administered per unit protocol by bedside clinical staff. 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).

02

Conditions studied

  • Airway Clearance Impairment
03

In context

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    High Oscillatory Index Device

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

    Device: High Oscillatory Index Device

  • Active comparator
    Low Oscillatory Index Device

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

    Device: Low Oscillatory Index Device

Interventions

  • DeviceHigh Oscillatory Index Device

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

    Also known as: Aerobika

  • DeviceLow Oscillatory Index Device

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

    Also known as: VibraPEP

06

What researchers measure

Primary outcomes

  1. Respiratory assess and treat (RAAT) score

    The RAAT score range from 0-50.

    Time frame: Change from baseline RAAT score at 12 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

  • Informed consent form · Feb 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05873504
Lead sponsor
Rush University Medical Center
Responsible party
Sponsor
First posted
May 24, 2023
Start date
May 1, 2023
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Feb 19, 2026

Study contacts

Lauren Harnois, MSc
Contact
Lauren_J_Harnois@rush.edu
312-947-8898
Ramandeep Kaur, PhD
Contact
Ramandeep_Kaur@rush.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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