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NCT Number: NCT05873504

Outcome Comparisons of Vibratory Airway Clearance Devices

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Oscillatory Index Device

Device

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

Other names: Aerobika

Low Oscillatory Index Device

Device

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

Other names: VibraPEP

Primary outcomes

  1. Respiratory assess and treat (RAAT) score

    Time frame: Change from baseline RAAT score at 12 hours

    The RAAT score range from 0-50.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Harnois, MSc

CONTACT

[email protected]

312-947-8898

Ramandeep Kaur, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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