Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
NCT ID: NCT02458300
Last Updated: 2016-03-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
77 participants
INTERVENTIONAL
2015-01-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)
NCT02853838
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
NCT00125450
Treatment of Pediatric Bronchiolitis
NCT03835936
Evaluation of the Effects of Respiratory Physiotherapy in Infants With Moderate Acute Bronchiolitis
NCT03753802
Mucociliary Clearance Techniques for Acute Bronchiolitis
NCT06689631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient Registries:
SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca.
Sample size
The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas:
Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0%
The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant.
Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62
Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Arm
Nebulized hypertonic saline. Aspiration of secretions
Nebulization of hypertonic saline
application of hypertonic saline serum through a mask fogging or a box fogging
Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.
Intervention Arm.
Nebulization of hypertonic saline. Application of Prolonged slow expiration technique (PSE) expiratory volume. Patient coughing Provocation (TP) Inspiratory maneuver to rhinopharyngeal cleaning DRR Aspiration of secretions
Nebulization of hypertonic saline
application of hypertonic saline serum through a mask fogging or a box fogging
Prolonged slow expiration technique (PSE)
Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
Patient coughing Provocation (TP)
Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
inspiratory maneuver to rhinopharyngeal cleaning DRR
After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nebulization of hypertonic saline
application of hypertonic saline serum through a mask fogging or a box fogging
Prolonged slow expiration technique (PSE)
Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
Patient coughing Provocation (TP)
Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
inspiratory maneuver to rhinopharyngeal cleaning DRR
After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
Aspiration of secretions
Suctioning with a probe by a vacuum system installed on the wall.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Relative or absolute contraindication CPT techniques included in the protocol.
* Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist.
* Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx.
* Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general.
* Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex
1 Month
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Católica San Antonio de Murcia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enrique Conesa Segura
PT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enrique E Conesa Segura, PT
Role: PRINCIPAL_INVESTIGATOR
MurciaSalud
Susana Beatriz S Reyes Dominguez, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
MurciaSalud
José J Rios Diaz, PhD, BiolSc, PT
Role: STUDY_CHAIR
Universidad Católica San Antonio de Murcia
Eduardo E Ramos Elbal, MD
Role: STUDY_CHAIR
MurciaSalud
Cristina C Palazón Carpe, MD
Role: STUDY_CHAIR
MurciaSalud
Maria Ángeles M Ruiz Pacheco, MD
Role: STUDY_CHAIR
MurciaSalud
Jaume J Enjuanes Llovet, MD
Role: STUDY_CHAIR
MurciaSalud
Sara S Francés Tarazona, MD
Role: STUDY_CHAIR
MurciaSalud
Sebastián S Gil Garcia, PT
Role: STUDY_CHAIR
MurciaSalud
Maía de los Ángeles M Martinez-Salazar Arboleas, PT
Role: STUDY_CHAIR
MurciaSalud
References
Explore related publications, articles, or registry entries linked to this study.
Aherne W, Bird T, Court SD, Gardner PS, McQuillin J. Pathological changes in virus infections of the lower respiratory tract in children. J Clin Pathol. 1970 Feb;23(1):7-18. doi: 10.1136/jcp.23.1.7.
Bohe L, Ferrero ME, Cuestas E, Polliotto L, Genoff M. [Indications of conventional chest physiotherapy in acute bronchiolitis]. Medicina (B Aires). 2004;64(3):198-200. Spanish.
Fischer GB, Teper A, Colom AJ. Acute viral bronchiolitis and its sequelae in developing countries. Paediatr Respir Rev. 2002 Dec;3(4):298-302. doi: 10.1016/s1526-0542(02)00268-3.
Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
Krause MF, Hoehn T. Chest physiotherapy in mechanically ventilated children: a review. Crit Care Med. 2000 May;28(5):1648-51. doi: 10.1097/00003246-200005000-00067.
Lanza FC, Wandalsen G, Dela Bianca AC, Cruz CL, Postiaux G, Sole D. Prolonged slow expiration technique in infants: effects on tidal volume, peak expiratory flow, and expiratory reserve volume. Respir Care. 2011 Dec;56(12):1930-5. doi: 10.4187/respcare.01067. Epub 2011 Jun 17.
McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. No abstract available.
Mellins RB. Pulmonary physiotherapy in the pediatric age group. Am Rev Respir Dis. 1974 Dec;110(6 Pt 2):137-42. doi: 10.1164/arrd.1974.110.6P2.137. No abstract available.
Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. doi: 10.1183/09031936.00.15119600.
Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.
Postiaux G. [Bronchiolitis in infants. What are the techniques of bronchial and upper airway respiratory therapy adapted to infants?]. Arch Pediatr. 2001 Jan;8 Suppl 1:117S-125S. doi: 10.1016/s0929-693x(01)80170-6. No abstract available. French.
Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004873. doi: 10.1002/14651858.CD004873.pub4.
Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
van der Schans CP. Forced expiratory manoeuvres to increase transport of bronchial mucus: a mechanistic approach. Monaldi Arch Chest Dis. 1997 Aug;52(4):367-70.
Webb MS, Martin JA, Cartlidge PH, Ng YK, Wright NA. Chest physiotherapy in acute bronchiolitis. Arch Dis Child. 1985 Nov;60(11):1078-9. doi: 10.1136/adc.60.11.1078.
Wohl ME, Chernick V. State of the art: bronchiolitis. Am Rev Respir Dis. 1978 Oct;118(4):759-81. doi: 10.1164/arrd.1978.118.4.759. No abstract available.
Zach MS, Oberwaldner B. Chest physiotherapy--the mechanical approach to antiinfective therapy in cystic fibrosis. Infection. 1987;15(5):381-4. doi: 10.1007/BF01647750.
Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FIBARRIX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.