Cystic Fibrosis Clinical Trial
Official title:
Intrapulmonary Percussive Ventilation vs Chest Physiotherapy Vest in Airway Clearance During Cystic Fibrosis Pulmonary Exacerbation
Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced
Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next
pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary
exacerbation.
FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF
patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials
because it is an acute indicator of worsening or improving lung function.
The study will be a prospective randomized clinical trial. All Cystic Fibrosis (CF) patients
five years and above who are being admitted to University of Florida (UF) Shands Children's
Hospital with the diagnosis of CF acute pulmonary exacerbations will be approached for study
consent on day one of hospitalization.
Each patient will be randomized to receive either IPV (metaneb) or Chest Physiotherapy (CPT)
vest (Incourage) therapy. Treatments will be administered by in-house respiratory therapists
four times daily according to standard protocol, and the respiratory therapist will document
each treatment in the patient's electronic medical record (EPIC). Each patient will also
receive mucolytic agents (dornase alpha, hypertonic saline) and antibiotic therapy as per
routine inpatient protocol per the attending pulmonologist on service. If the patient's
clinical status worsens during their admission the attending pulmonologist will be allowed to
change the airway clearance regimen or antibiotic coverage at their discretion.
If a patient is enrolled and has another admission for pulmonary exacerbation after their
initial admission, we will attempt to randomize them to the other arm and utilize this data
to see if there is a difference in outcome parameters for the same patient if they are
randomized to both arms.
The degree of improvement in FEV1 defined as absolute difference between admission FEV1 and
discharge FEV1 will be used as primary outcome measure to compare effectiveness between both
modalities. This measure is commonly used in the Cystic Fibrosis community of clinicians and
researchers as measure of airway obstruction and disease severity. We will perform spirometry
at least twice, at admission and discharge, on these patients. The patient's spirometry from
their office visit on the same day of admission or first spirometry during their admission
will count as the initial spirometry. Last spirometry obtained before discharge will be the
discharge spirometry. Additional spirometry may be performed during the patient's admission
at the attending provider's clinical discretion. We will also use data from these additional
spirometry measurements if they take place.
There will be no additional cost incurred by using the IPV device as opposed to standard of
care (CPT vest).There is also no increased effort performing IPV treatments from the
respiratory therapist performing the treatment or from the patient.
Length of hospital stay in days will be used as a secondary outcome.
Another secondary outcome measure will be the length of time between discharge and subsequent
admissions for CF pulmonary exacerbation. We will follow the subject for an additional 6
months after they are enrolled to ascertain the time to next admission and total number of
admissions in that time.
Other information that will be accessed through EPIC records will be number of admissions for
CF pulmonary exacerbations, airway clearance regimen, radiological data, laboratory results
(respiratory cultures, Respiratory Viral Panels, Acid Fast Bacilli cultures, complete Blood
counts), vital signs, weight measurements, Bronchoscopy reports, medications used (Orkambi,
Kalydeco, antibiotics), and oxygen requirement. All of this information will be collected in
the time period of 1 year before study and throughout study,
We will also administer a 2 question questionnaire at the beginning and end of admission to
the hospital in order to evaluate the patient/family opinion of the therapy they received
during their participation in the study.
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