Outcome Comparisons of Vibratory Airway Clearance Devices

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Clearance Impairment
• Intervention / Treatment: Device: High Oscillatory Index Device; Device: Low Oscillatory Index Device

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramandeep Kaur, PhD; Email: Ramandeep_Kaur@rush.edu
• Study Contact Backup: Name: Lauren Harnois, MSc; Phone Number: 312-947-8898; Email: Lauren_J_Harnois@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Ramandeep Kaur, PhD; Email: Ramandeep_Kaur@rush.edu
      • Contact: Lauren Harnois, MSc; Phone Number: 312-947-8898; Email: Lauren_J_Harnois@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Oscillatory Index Device; Patients in this arm will receive a device that vibrates with high oscillatory index.	Device: High Oscillatory Index Device; This device is commonly used to provide assistance with airway secretion clearance.; Other Names: Aerobika
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; This device is commonly used to provide assistance with airway secretion clearance.; Other Names: VibraPEP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23011705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No