Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Wet sputum production
Study Overview
Brief Summary
This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).
Detailed Description
All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.
During the study period the patients' pharmacological treatment remains unchanged
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pass the inhalation test
- •Chronic sputum production, at least ≥ 10 ml /24h
- •Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- •Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
- •Trained in the use of autogenic drainage technique (at least 6 months)
- •Inhaling hypertonic saline since at least 6 months
- •To be able to provide written, informed consent and perform the protocol and the evaluations
Exclusion Criteria
- •Active massive hemoptysis during the previous 2 months
- •Patient in transplantation or retransplantation list
- •Patient already participating in another study at the same time
Arms & Interventions
USUAL CARE
Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.
INHALATION WITH PEP DEVICE
Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.
Intervention: INHALATION WITH PEP DEVICE (Acapella Duet) (Device)
Outcomes
Primary Outcomes
Wet sputum production
Time Frame: 45 minutes
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
Secondary Outcomes
- Lung function (simply spirometry)(5 days)
- Patient's perception (Likert test)(5 days)
- Questionnaire(5 days)
- Wet sputum production(22 hours)
- Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)(45 minutes)
- Wet sputum production(2 hours)