Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Ethical Considerations
2.2. Patients
2.3. Interventions
2.4. Assessments
2.5. Statistical Analyses
2.6. Comparison of Treatments
2.7. Comparisons of Treatments Versus Baseline
3. Results
3.1. Baseline Characteristics of the Study Group
3.2. Pulmonary Function Test Results
3.3. Mixed-Model Analysis Results
3.4. Simeox® Treatment Satisfactory Questionnaire
3.5. Adverse Events
4. Discussion
4.1. Spirometry, PFT, IOS, Multiple-Breath Washout, CFQ-R
4.2. Safety Results Discussion
4.3. Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Group Using the Simeox® Technique | Group Using the CPT Technique | |
---|---|---|
Morning | MDI or DPI bronchodilator | MDI or DPI bronchodilator |
Nebulization with physiological or hypertonic saline solution | Nebulization with physiological or hypertonic saline solution | |
Autogenic drainage, drainage with Simeox® technique for 20 min. | Autogenic drainage for 20 min. | |
Afternoon | Physical activity | Physical activity |
Autogenic drainage, drainage with Simeox® technique for 20 min | Autogenic drainage for 20 min | |
Nebulization with dornase alfa. | Nebulization with dornase alfa. | |
Evening | MDI or DPI bronchodilatorNebulization with physiological or hypertonic saline solutionDrainage with O-PEP (Aerobika, Flutter, Acapella) for 20 min. | MDI or DPI bronchodilator |
Nebulization with physiological or hypertonic saline solution | ||
Drainage with O-PEP (Aerobika, Flutter, Acapella) for 20 min. |
Demographic Characteristics | All Patients n = 40 | Group A n = 20 | Group B n = 20 |
---|---|---|---|
Female, n | 22 | 12 | 10 |
Male, n | 18 | 8 | 10 |
Age of patient (years), Mean ± SD | 13.02 ± 2.80 | 13.03 ± 3.05 | 13.01 ± 2.61 |
Height (cm), Mean ± SD | 154.43 ± 13.87 | 152.40 ± 14.07 | 156.45 ± 13.72 |
Weight (kg), Mean ± SD | 45.16 ± 12.52 | 42.89 ± 12.07 | 47.42 ± 12.86 |
BMI (kg/cm²), Mean ± SD | 18.53 ± 2.47 | 18.06 ± 2.42 | 19.00 ± 2.49 |
Comorbidities | |||
Pancreatic insufficiency, n (%) | 36 (90.0) | 19 (95.0) | 17 (85.0) |
Diabetes, n (%) | 15 (37.5) | 9 (45.0) | 6 (30.0) |
Sinus polyposis, n (%) | 26 (65.0) | 14 (70.0) | 12 (60.0) |
Cirrhosis, n (%) | 1 (2.5) | 1 (5.0) | 0 (0) |
Chronic pseudomonas aeruginosa, n (%) | 8 (20.0) | 6 (30.0) | 2 (10.0) |
Criteria | Simeox® | Conventional | Simeox®—Conventional | p-Value |
---|---|---|---|---|
Estimated adjusted Means ± SE or Medians (Q1; Q3) | Estimated Treatment Effect [CI95%] | Uncorrected/Corrected § | ||
Impulse Oscillometry | ||||
R 5 Hz | 0.45 ± 0.01 | 0.44 ± 0.01 | 0.01 [−0.01; 0.03] | 0.457/0.810 |
R 5–R 20 Hz | 0.06 (0.03; 0.10) | 0.06 (0.03; 0.09) | 0.00 | 0.217/0.651 |
R 20 Hz | 0.38 ± 0.01 | 0.38 ± 0.01 | −0.00 [−0.02; 0.02] | 0.721/0.824 |
X 5 Hz ** | 0.00 ± 0.01 | 0.03 ± 0.01 | −0.03 [−0.06; 0.00] | 0.060/0.394 |
AX | 0.50 (0.34; 0.860) | 0.45 (0.35; 0.76) | 0.05 | 0.393/0.810 |
Spirometry | ||||
FEV1 z-score | −0.57 (−1.25; 0.27) | −0.82 (−1.37; 0.37) | 0.25 | 0.746/0.824 |
FVC z-score | −0.31 ± 0.08 | −0.26 ± 0.08 | −0.04 [−0.21; 0.19] | 0.586/0.810 |
MEF25 z-score | −1.23 ± 0.13 | −1.26 ± 0.13 | 0.03 [−0.23; 0.30] | 0.785/0.825 |
MEF50 z-score | −0.53 (−1.38; 0.40) | −0.49 (−1.25; 1.12) | 0.04 | 0.094/0.394 |
MEF75 z-score | 5.31 ± 1.04 | 4.95 ± 1.04 | 0.36 [0.02; 0.13] | 0.008 */0.159 |
Lung-clearance index | ||||
LCI 2.5 ** | −0.37 ± 0.34 | 0.54 ± 0.34 | −0.91 [−1.93; 0.11] | 0.079/0.394 |
LCI 2.5 z-score ** | −0.31 ± 0.57 | 0.93 ± 0.57 | −1.24 [−2.97; 0.50] | 0.156/0.545 |
Body plethysmography | ||||
RV z-score | 0.55 ± 0.26 | 0.39 ± 0.26 | 0.16 [−0.46; 0.77] | 0.603/0.810 |
TLC z-score | −0.20 ± 0.17 | −0.10 ± 0.17 | −0.10 [−0.49; 0.29] | 0.617/0.810 |
RV/TLC z-score ** | 0.09 ± 0.50 | −0.48 ± 0.51 | 0.57 [−0.97; 2.10] | 0.460/0.810 |
FRC z-score | 0.64 (−0.66; 1.84) | 0.32 (−0.85; 1.88) | 0.32 | 0.519/0.810 |
Reff z-score | 0.86 (0.01; 2.06) | 0.79 (−0.39; 2.11) | 0.07 | 0.524/0.810 |
sReff z-score | 1.58 (0.87; 3.01) | 1.55 (0.45; 2.90) | 0.03 | 0.519/0.810 |
Rtot z-score | 1.74 ± 0.09 (in log scale) | 1.72 ± 0.09 (in log scale) | 0.02 [−0.12; 0.17] | 0.743/0.824 |
Criteria | Simeox® | Conventional | Simeox®—Conventional | p-Value |
---|---|---|---|---|
Estimated Adjusted Means ± SE or Medians (Q1; Q3) | Estimated Treatment Effect [CI95%] | Uncorrected/Corrected | ||
Cystic Fibrosis questionnaire (CFQ-R) | ||||
Physical score (patient) | 90.4 ± 1.61 | 87.0 ± 1.61 | 3.37 [0.56; 6.17] | 0.015 */0.159 |
Respiratory score (patient) | 82.7 ± 1.63 | 82.5 ± 1.63 | 0.21 [−3.04; 3.46] | 0.897/0.897 |
Criteria | Baseline ** | Simeox® Treatment | Conventional Treatment | ||
---|---|---|---|---|---|
After Treatment | Baseline–Treatment | After Treatment | Baseline–Treatment | ||
Adjusted Means ± SE or Medians (Q1; Q3) | Adjusted Means ± SE or Medians (Q1; Q3) | Treatment Effect [CI95%] Uncorrected/Corrected § p-Value | Adjusted Means ± SE or Medians (Q1; Q3) | Treatment Effect [CI95%] Uncorrected/Corrected § p-Value | |
Impulse Oscillometry | |||||
R 5 Hz | 0.48 ± 0.03 | 0.45 ± 0.02 | 0.03 [0.00; 0.05] -/0.067 | 0.44 ± 0.02 | 0.03 [0.00; 0.06] -/0.013 * |
R 5- R 20 Hz | 0.06 (0.03; 0.10) | 0.06 (0.03; 0.10) | 0.00 0.576/0.576 | 0.06 (0.03; 0.09) | 0.00 0.138/0.275 |
R 20 Hz | 0.40 ± 0.02 | 0.38 ± 0.02 | 0.02 [0.00; 0.04] -/0.047 * | 0.38 ± 0.02 | 0.02 [0.00; 0.04] -/0.103 |
X 5 Hz | −0.17 (−0.20; −0.11) | −0.16 (−0.19; −0.12) | 0.01 0.432/0.432 | −0.15 (−0.19; −0.12) | 0.02 0.038 */0.077 |
AX | 0.54 (0.30; 0.89) | 0.50 (0.34; 0.86) | 0.04 0.673/0.106 | 0.45 (0.35; 0.76) | 0.09 0.053/0.135 |
Spirometry | |||||
FEV1 z-score | Group A **: −1.16 (−2.66; −0.40) | −0.79 (−1.93; −0.24) | 0.37 0.779/0.779 | −0.55 (−0.91; 0.39) | −0.26 0.092/0.186 |
Group B **: −0.29 (−0.45; 0.40) | |||||
FVC z-score | −0.24 ± 0.19 | −0.29 ± 0.20 | 0.05 [−0.20; 0.30] -/0.871 | −0.33 ± 0.20 | 0.09 [−0.16; 0.34] -/0.657 |
MEF25 z-score | −1.08 ± 0.24 | −1.23 ± 0.24 | 0.15 [−0.17; 0.46] -/0.503 | −1.26 ± 0.24 | 0.18 [−0.13; 0.50] -/0.351 |
MEF50 z-score | −0.21 ± 0.28 | −0.55 ± 0.28 | 0.34 [0.00; 0.67] -/0.048 * | −0.37 ± 0.28 | 0.16 [−0.177; 0.492] -/0.503 |
MEF75 z-score | −0.13 (−1.45; 0.42) | 0.12 (−1.11; 0.82) | −0.24 0.134/0.267 | −0.23 (−1.37; 0.38) | 0.10 0.572/0.572 |
Lung-clearance index | |||||
LCI 2.5 | Group A **: 12.20 ± 0.89 | 11.60 ± 0.89 | 0.51 [−0.27; 1.29] 0.169/0.169 | 9.87 ± 0.61 | −0.69 [−1.27; −0.11] 0.014 */0.027 * |
Group B **: 9.19 ± 0.61 | |||||
LCI 2.5 z-score | Group A **: 10.1 (7.7; 13.4) | 9.40 (6.65; 12.60) | 0.07 0.365/0.365 | 7.10 (4.35; 9.35) | −0.80 0.007 */0.014 * |
Group B **: 6.3 (2.62; 8.9) | |||||
Body plethysmography | |||||
RV z-score | Group A **: 1.64 (0.31; 2.55) | 1.42 (0.14; 2.58) | 0.22 0.126/0.252 | 0.17 (−0.46; 1.14) | −0.05 0.587/0.587 |
Group B **: 0.12 (−0.99; 0.86) | |||||
TLC z-score | 0.25 (−1.46; 0.77) | 0.05 (−0.83; 1.06) | 0.20 0.620/1.000 | −0.26 (−0.98; 0.88) | 0.51 0.558/1.000 |
RV/TLC z-score | 1.10 ± 0.37 | 1.21 ± 0.51 | −0.11 [−1.46; 2.12] -/0.979 | 0.33 ± 0.51 | 0.77 [−0.58; 0.50] -/0.356 |
FRC z-score | 0.55 ± 0.34 | 0.38 ± 0.34 | 0.17 [−0.41; 0.75] -/0.753 | 0.50 ± 0.34 | 0.05 [−0.53; 0.63] -/0.974 |
Reff z-score | 1.04 (−0.38; 3.16) | 0.86 (0.01; 2.06) | 0.19 0.715/0.779 | 0.79 (−0.39; 2.11) | 0.26 0.390/0.779 |
sReff z-score | 2.78 ± 0.65 | 2.62 ± 0.65 | 0.16 [−0.66; 0.97] -/0.890 | 2.61 ± 0.65 | 0.16 [−0.65; 0.98] -/0.880 |
Rtot z-score | 1.31 ± 0.09 (in log scale) | 1.33 ± 0.09 (in log scale) | −0.01 [−0.18; 0.16] -/0.979 | 1.30 ± 0.09 (in log scale) | 0.01 [−0.16; 0.18] -/0.991 |
Cystic Fibrosis Questionnaire (CFQ-R) | Baseline ** | Simeox® Treatment | Conventional Treatment | ||
---|---|---|---|---|---|
After Treatment | Baseline–Treatment | After Treatment | Baseline–Treatment | ||
Adjusted Means ± SE or Medians (Q1; Q3) | Adjusted Means ± SE or Medians (Q1; Q3) | Treatment Effect [CI95%] Uncorrected/Corrected § p-Value | Adjusted Means ± SE or Medians (Q1; Q3) | Treatment Effect [CI95%] Uncorrected/Corrected § p-Value | |
Physical score (patient) | 85.3 ± 2.1 | 90.4 ± 2.1 | −5.10 [−9.09; −1.12] -/0.009 * | 87.0 ± 2.1 | −1.74 [−5.73; 2.25] -/0.554 |
Respiratory score (patient) | 80.4 ± 2.01 | 82.7 ± 2.01 | −2.29 [−6.52; 1.93] -/0.402 | 82.5 ± 2.01 | −2.08 [−6.31; 2.14] -/0.470 |
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Sands, D.; Walicka-Serzysko, K.; Milczewska, J.; Postek, M.; Jeneralska, N.; Cichocka, A.; Siedlecka, E.; Borawska-Kowalczyk, U.; Morin, L. Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children 2023, 10, 204. https://doi.org/10.3390/children10020204
Sands D, Walicka-Serzysko K, Milczewska J, Postek M, Jeneralska N, Cichocka A, Siedlecka E, Borawska-Kowalczyk U, Morin L. Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children. 2023; 10(2):204. https://doi.org/10.3390/children10020204
Chicago/Turabian StyleSands, Dorota, Katarzyna Walicka-Serzysko, Justyna Milczewska, Magdalena Postek, Natalia Jeneralska, Aleksandra Cichocka, Ewa Siedlecka, Urszula Borawska-Kowalczyk, and Laurent Morin. 2023. "Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial" Children 10, no. 2: 204. https://doi.org/10.3390/children10020204
APA StyleSands, D., Walicka-Serzysko, K., Milczewska, J., Postek, M., Jeneralska, N., Cichocka, A., Siedlecka, E., Borawska-Kowalczyk, U., & Morin, L. (2023). Efficacy of the Simeox® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children, 10(2), 204. https://doi.org/10.3390/children10020204