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

NCT02458300 | Completed

• 1 other identifier: FIBARRIX
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Chest; Physical therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment

  Participants will be followed for the duration of hospital stay, an expected average of 7 days

• 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

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Nebulized hypertonic saline. Aspiration of secretions

Other: Nebulization of hypertonic saline; Other: Aspiration of secretions

Intervention Arm.

ACTIVE COMPARATOR

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

Other: Nebulization of hypertonic saline; Other: Prolonged slow expiration technique (PSE); Other: Patient coughing Provocation (TP); Other: inspiratory maneuver to rhinopharyngeal cleaning DRR; Other: Aspiration of secretions

Interventions

Nebulization of hypertonic saline OTHER

application of hypertonic saline serum through a mask fogging or a box fogging

Control Arm; Intervention Arm.

Prolonged slow expiration technique (PSE) OTHER

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 Arm.

Patient coughing Provocation (TP) OTHER

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 Arm.

inspiratory maneuver to rhinopharyngeal cleaning DRR OTHER

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 Arm.

Aspiration of secretions OTHER

Suctioning with a probe by a vacuum system installed on the wall.

Control Arm; Intervention Arm.

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Related Publications (20)

• 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.

  PMID: 4909103 BACKGROUND

• 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.

  PMID: 15239532 BACKGROUND

• 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.

  PMID: 12457599 BACKGROUND

• 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.

  PMID: 20927359 BACKGROUND

• 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.

  PMID: 22499404 BACKGROUND

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

  PMID: 17894906 BACKGROUND

• 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.

  PMID: 10834729 BACKGROUND

• 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.

  PMID: 21682953 BACKGROUND

• McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. No abstract available.

  PMID: 6847951 BACKGROUND

• 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.

  PMID: 4613219 BACKGROUND

• Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. doi: 10.1183/09031936.00.15119600.

  PMID: 10678646 BACKGROUND

• 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.

  PMID: 21352671 BACKGROUND

• 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.

  PMID: 11232428 BACKGROUND

• 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.

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

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• 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.

  PMID: 9401368 BACKGROUND

• 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.

  PMID: 3907510 BACKGROUND

• 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.

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• 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.

  PMID: 3319913 BACKGROUND

• 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.

  PMID: 37010196 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Enrique E Conesa Segura, PT

  MurciaSalud

  PRINCIPAL INVESTIGATOR

• Susana Beatriz S Reyes Dominguez, PhD,MD

  MurciaSalud

  PRINCIPAL INVESTIGATOR

• José J Rios Diaz, PhD, BiolSc, PT

  Universidad Católica San Antonio de Murcia

  STUDY CHAIR

• Eduardo E Ramos Elbal, MD

  MurciaSalud

  STUDY CHAIR

• Cristina C Palazón Carpe, MD

  MurciaSalud

  STUDY CHAIR

• Maria Ángeles M Ruiz Pacheco, MD

  MurciaSalud

  STUDY CHAIR

• Jaume J Enjuanes Llovet, MD

  MurciaSalud

  STUDY CHAIR

• Sara S Francés Tarazona, MD

  MurciaSalud

  STUDY CHAIR

• Sebastián S Gil Garcia, PT

  MurciaSalud

  STUDY CHAIR

• Maía de los Ángeles M Martinez-Salazar Arboleas, PT

  MurciaSalud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 1, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 2, 2016

Record last verified: 2015-05