Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Physiotherapy is a key treatment for patients with bronchiectasis. An evaluation of the parameters indicative of respiratory health in patients treated with two different respiratory physiotherapy techniques (conventional versus Simeox®) would be very useful in choosing physiotherapy treatments for bronchiectasis patients. A systematic review of the literature shows that there are no published studies evaluating the effectiveness of respiratory physiotherapy by analyzing the variation in resistance measured using the forced oscillation technique (FOT) in patients with bronchiectasis. The results of this study would add to those that have examined different physiotherapy techniques and could therefore contribute to the choice of the most appropriate technique for this category of patients. The trial is being conducted to answer the question: How do respiratory parameters vary during treatment with two different respiratory physiotherapy techniques: conventional respiratory physiotherapy or that performed using the Simeox device? Secondary objectives include the measurement of various functional parameters, such as vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure values) and spirometry values (FEV1, FVC, TLC). The onset of adverse events, the degree of patient tolerance and relief, and respiratory health will also be assessed through the administration of various questionnaires commonly used in clinical practice. Additionally, changes in the quantity of sputum produced will be measured.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized.

• Age ≥ 18 years.

• Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the 10 years prior to enrollment.

• Absence of exacerbations in the 28 days preceding enrollment.

• Sputum producers with volumes less than or equal to 200 mL/day.

• Under treatment with optimized standard therapy for bronchiectasis that has been stable for at least one year, with no changes in the 28 days prior to enrollment.

• Eligible for and/or already undergoing respiratory physiotherapy.

• Signed informed consent.

Locations
Other Locations
Italy
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Stefano Nava, MD
stefano.nava@aosp.bo.it
+39 0512143253
Backup
Vittoria Comellini, MD
vittoria.comellini@aosp.bo.it
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 40
Treatments
Other: Arm A
Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinic and they will switch to Simeox for the second treatment
Other: Arm B
Patients randomized to Group B will undergo the first treatment with Simeox, and they will switch to conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinicfor the second treatment
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov