Airway Clearance ImpairmentNCT05873504
Outcome Comparisons of Vibratory Airway Clearance Devices
A study testing High Oscillatory Index Device and Low Oscillatory Index Device in people with Airway Clearance Impairment, run by Rush University Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Clearance Impairment
- What is being tested?
- High Oscillatory Index Device and Low Oscillatory Index Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ramandeep Kaur, PhD contact
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Lauren Harnois, MSc, 312-947-8898, Lauren_J_Harnois@rush.edu
Ramandeep Kaur, PhD, Ramandeep_Kaur@rush.edu
About this study
Official title: Outcome Comparisons of Two Vibratory Positive Expiratory Pressure Devices in Patients Unable to Clear Airway Secretions
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).
- Conditions
- Airway Clearance Impairment
- Being tested
- High Oscillatory Index Device, Low Oscillatory Index Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Oscillatory Index DeviceDevice
Also called Aerobika
This device is commonly used to provide assistance with airway secretion clearance.
Low Oscillatory Index DeviceDevice
Also called VibraPEP
This device is commonly used to provide assistance with airway secretion clearance.
| Study group | Role | What they receive |
|---|---|---|
| High Oscillatory Index Device | Experimental | Patients in this arm will receive a device that vibrates with high oscillatory index. Receives: Device: High Oscillatory Index Device |
| Low Oscillatory Index Device | Active comparator | Patients in this arm will receive a device that vibrates with low oscillatory index. Receives: Device: Low Oscillatory Index Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory assess and treat (RAAT) score
The RAAT score range from 0-50.
Measured: Change from baseline RAAT score at 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 May 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Clearance ImpairmentStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873504
- Sponsor's protocol ID
- 23011705
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Comparisons of Two Vibratory Positive Expiratory Pressure Devices in Patients Unable to Clear Airway Secretions
- ClinicalTrials.gov ID
- NCT05873504
- Acronym / sponsor ID
- 23011705
- Conditions
- Airway Clearance Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Oscillatory Index Device | Experimental | Device: High Oscillatory Index DevicePatients in this arm will receive a device that vibrates with high oscillatory index. |
| Low Oscillatory Index Device | Active comparator | Device: Low Oscillatory Index DevicePatients in this arm will receive a device that vibrates with low oscillatory index. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years or older
- Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Oscillatory Index DeviceAlso: AerobikaThis device is commonly used to provide assistance with airway secretion clearance. | Device | High Oscillatory Index Device |
| Low Oscillatory Index DeviceAlso: VibraPEPThis device is commonly used to provide assistance with airway secretion clearance. | Device | Low Oscillatory Index Device |
Primary outcome
Respiratory assess and treat (RAAT) score
Time frame: Change from baseline RAAT score at 12 hours
The RAAT score range from 0-50.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramandeep Kaur, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Oscillatory Index Device and Low Oscillatory Index Device in people with Airway Clearance Impairment, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Harnois, MSc (312-947-8898, Lauren_J_Harnois@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory assess and treat (RAAT) score (time frame: Change from baseline RAAT score at 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.