Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
NCT ID: NCT02303808
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-12-31
2015-11-30
Brief Summary
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Detailed Description
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During the study period the patients' pharmacological treatment remains unchanged
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
INHALATION WITH PEP DEVICE (Acapella Duet)
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
Interventions
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INHALATION WITH PEP DEVICE (Acapella Duet)
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient in transplantation or retransplantation list
* Patient already participating in another study at the same time
16 Years
ALL
No
Sponsors
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Universidad San Jorge
OTHER
Responsible Party
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Principal Investigators
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Marta San Miguel
Role: PRINCIPAL_INVESTIGATOR
Universidad San Jorge
Locations
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Asociación Aragonesa de Fibrosis Quística
Zaragoza, , Spain
Countries
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References
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Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.
San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.
Other Identifiers
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239|2012
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FQ_INH_PEP_01
Identifier Type: -
Identifier Source: org_study_id