Outcome Comparisons of Vibratory Airway Clearance Devices

Airway Clearance Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873504
• Other study ID #: 23011705
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: David Vines, PhD
• Phone: 312-942-4408
• Email: David_Vines[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 post extubation or within first 48 hours of ICU admission

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

Related Conditions & MeSH terms

• Airway Clearance Impairment

Intervention

Device:
• High Oscillatory Index Device
This device is commonly used to provide assistance with airway secretion clearance.
• Low Oscillatory Index Device
This device is commonly used to provide assistance with airway secretion clearance.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory assess and treat (RAAT) score	The RAAT score range from 0-50.	Change from baseline RAAT score at 12 hours