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Recruiting NCT05873504

Outcome Comparisons of Vibratory Airway Clearance Devices

No phase Interventional Airway Clearance Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Oscillatory Index Device, Low Oscillatory Index Device.
Who it may be relevant to
Registry conditions: Airway Clearance Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Respiratory assess and treat (RAAT) score [Time frame: Change from baseline RAAT score at 12 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT05873504 · 23011705

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗