Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis

Bronchiolitis Clinical Trial

— FIBARRIX  

Official title:

FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458300
• Other study ID #: FIBARRIX
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: March 1, 2016
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 2 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

References & Publications (19)

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. — View Citation

Bohé 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. — View 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. Review. — View 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. — View 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. Epub 2012 Apr 12. — View Citation

Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6. — View Citation

Krause MF, Hoehn T. Chest physiotherapy in mechanically ventilated children: a review. Crit Care Med. 2000 May;28(5):1648-51. Review. — View Citation

Lanza FC, Wandalsen G, Dela Bianca AC, Cruz CL, Postiaux G, Solé 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. — View Citation

McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. — View Citation

Mellins RB. Pulmonary physiotherapy in the pediatric age group. Am Rev Respir Dis. 1974 Dec;110(6 Pt 2):137-42. Review. — View Citation

Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. Review. — View 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. — View 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. Review. French. — View Citation

Roqué i Figuls M, Giné-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. Review. Update in: Cochrane Database Syst Rev. 2016;2:CD004873. — View Citation

Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1. Review. — View 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. Review. — View 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. — View Citation

Wohl ME, Chernick V. State of the art: bronchiolitis. Am Rev Respir Dis. 1978 Oct;118(4):759-81. — View Citation

Zach MS, Oberwaldner B. Chest physiotherapy--the mechanical approach to antiinfective therapy in cystic fibrosis. Infection. 1987;15(5):381-4. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis		Participants will be followed for the duration of hospital stay, an expected average of 7 days	No
Secondary	Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols		Participants will be followed for the duration of hospital stay, an expected average of 7 days	No
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 7 days	No
Secondary	To quantify the changes in clinical score severity scale.		Participants will be followed for the duration of hospital stay, an expected average of 7 days	No