Outcome Comparisons of Vibratory Airway Clearance Devices

Status Recruiting

Clinical 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.

Clinical Trial Description

This pilot study is a randomized control trial of adult patients admitted to an academic medical center from April 2023 to April 2024. 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 post extubation or within the first 48 hours of ICU admission. 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. After randomization, the study team will give the device to the patient and administer instructions on the device use. 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

Related Conditions & MeSH terms

Airway Clearance Impairment

Clinical Trial Details

NCT number	NCT05873504
Study type	Interventional
Source	Rush University Medical Center
Contact	David Vines, PhD
Phone	312-942-4408
Email	David_Vines@rush.edu
Status	Recruiting
Phase	N/A
Start date	May 1, 2023
Completion date	April 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.