Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis (FIBARRIX)
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nebulization of hypertonic saline
Prolonged slow expiration technique (PSE)
Patient coughing Provocation (TP)
inspiratory maneuver to rhinopharyngeal cleaning DRR
Aspiration of secretions
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Chest, Physical therapy
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).
Exclusion Criteria:
- Presence of cyanotic congenital heart disease no longer for comparing the constants.
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Arm
Intervention Arm.
Arm Description
Nebulized hypertonic saline. Aspiration of secretions
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
Outcomes
Primary Outcome Measures
Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
Secondary Outcome Measures
Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
To quantify the changes in clinical score severity scale.
Full Information
NCT ID
NCT02458300
First Posted
May 20, 2015
Last Updated
March 1, 2016
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT02458300
Brief Title
Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
Acronym
FIBARRIX
Official Title
FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.
Detailed Description
This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis.
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Chest, Physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Nebulized hypertonic saline. Aspiration of secretions
Arm Title
Intervention Arm.
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Nebulization of hypertonic saline
Intervention Description
application of hypertonic saline serum through a mask fogging or a box fogging
Intervention Type
Other
Intervention Name(s)
Prolonged slow expiration technique (PSE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient coughing Provocation (TP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
inspiratory maneuver to rhinopharyngeal cleaning DRR
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Aspiration of secretions
Intervention Description
Suctioning with a probe by a vacuum system installed on the wall.
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Outcome Measure Information:
Title
Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
Description
A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
To quantify the changes in clinical score severity scale.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).
Exclusion Criteria:
Presence of cyanotic congenital heart disease no longer for comparing the constants.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique E Conesa Segura, PT
Organizational Affiliation
MurciaSalud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susana Beatriz S Reyes Dominguez, PhD,MD
Organizational Affiliation
MurciaSalud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José J Rios Diaz, PhD, BiolSc, PT
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo E Ramos Elbal, MD
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina C Palazón Carpe, MD
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Ángeles M Ruiz Pacheco, MD
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaume J Enjuanes Llovet, MD
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara S Francés Tarazona, MD
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sebastián S Gil Garcia, PT
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maía de los Ángeles M Martinez-Salazar Arboleas, PT
Organizational Affiliation
MurciaSalud
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
4909103
Citation
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.
Results Reference
background
PubMed Identifier
15239532
Citation
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.
Results Reference
background
PubMed Identifier
12457599
Citation
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.
Results Reference
background
PubMed Identifier
20927359
Citation
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.
Results Reference
background
PubMed Identifier
22499404
Citation
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.
Results Reference
background
PubMed Identifier
17894906
Citation
Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
Results Reference
background
PubMed Identifier
10834729
Citation
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.
Results Reference
background
PubMed Identifier
21682953
Citation
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.
Results Reference
background
PubMed Identifier
6847951
Citation
McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. No abstract available.
Results Reference
background
PubMed Identifier
4613219
Citation
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.
Results Reference
background
PubMed Identifier
10678646
Citation
Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. doi: 10.1183/09031936.00.15119600.
Results Reference
background
PubMed Identifier
21352671
Citation
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.
Results Reference
background
PubMed Identifier
11232428
Citation
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.
Results Reference
background
PubMed Identifier
22336805
Citation
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.
Results Reference
background
PubMed Identifier
17894905
Citation
Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
Results Reference
background
PubMed Identifier
9401368
Citation
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.
Results Reference
background
PubMed Identifier
3907510
Citation
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.
Results Reference
background
PubMed Identifier
212970
Citation
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.
Results Reference
background
PubMed Identifier
3319913
Citation
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.
Results Reference
background
Learn more about this trial
Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
We'll reach out to this number within 24 hrs