Skip to content

Outcome Comparisons of Vibratory Airway Clearance Devices

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05873504
Enrollment
64
Registered
2023-05-24
Start date
2023-05-01
Completion date
2026-12-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Clearance Impairment

Brief 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.

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).

Interventions

DEVICEHigh Oscillatory Index Device

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

DEVICELow Oscillatory Index Device

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

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory assess and treat (RAAT) scoreChange from baseline RAAT score at 12 hoursThe RAAT score range from 0-50.

Countries

United States

Contacts

CONTACTLauren Harnois, MSc
Lauren_J_Harnois@rush.edu312-947-8898
CONTACTRamandeep Kaur, PhD
Ramandeep_Kaur@rush.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026