Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)

Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial

The purpose of this research is to determine the effect of prolonged slow expiration techniques, provoked coughing and standard therapy compared to chest wall manual vibration and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of supplementary oxygen.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis, Viral
• Intervention / Treatment: Other: Prolonged slow expiration+provoked coughing; Other: Standard Therapy; Other: Manual chest wall vibration

Detailed Description

Bronchiolitis is the main cause of hospital admission for infants under 1 year old in Chile. Currently, approximately 4800 children are admitted to the hospital during the cold season, affecting the health services' effectiveness. The most frequent causal agent is the Respiratory Syncytial Virus (RSV). To date, there is no specific treatment for this disease and only support measures are recommended.

Chest physiotherapy is a support measure that improves the mucociliary clearance and reduces obstruction of the airways.

A clinical trial on the effect of prolonged slow expiration (PSE), chest wall vibrations, and provoked coughing as treatment for bronchiolitis in infants admitted to the hospital found that the subgroup with RSV required oxygen for 10 hours less than the control group. Gomes and Postiaux (2012) reported a 50% decrease on respiratory distress measured by the Wang score when PSE and suction were compared to traditional chest physiotherapy techniques in patients with bronchiolitis RSV(+).

Currently recommendations in Chile suggest chest physiotherapy for outpatients with bronchiolitis, but the guideline does not refer to the case of inpatients. It is proposed to carry out a randomized controlled trial in infants under one year old. The active group will receive standard therapy, PSE, and provoked coughing, while the control group will receive standard therapy and manual chest wall vibrations. The effectiveness of chest physiotherapy will be measured though a clinical score of respiratory distress, hours using supplementary oxygen, vital signs before and after the intervention in both groups during hospital stay. The main outcome is clinical severity score 48 hours after admission.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Hospital Padre Hurtado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of bronchiolitis.
• RSV positive in direct immunofluorescence assay.
• Wang clinical severity score ≥ 4 points.

Exclusion Criteria:

• Patients with heart or neurological diseases.
• Previous episodes of wheezing.
• Chronic conditions such as bronchopulmonary dysplasia, immunodeficiency, or congenital diseases.
• Need of mechanical ventilation in Intensive Care Unit
• Contraindication criteria for chest physiotherapy (i.e. Pneumothorax, ribs fractures, hemodynamic instability).
• Patients not receiving supplementary oxygen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prolonged slow expiration+provoked coughing+ST; Prolonged slow expiration+provoked coughing+Standard Therapy	Other: Prolonged slow expiration+provoked coughing; Five cycles of prolonged slow expiration and provoked coughing, which will be repeated five times. During the prolonged slow expiration, the infant will be in supine while the therapist applies pressure at the same time on the rib cage and abdomen during spontaneous expiration. The pressure is applied slowly during two o three respiratory cycles, only during the final phase of expiration.; Other: Standard Therapy; Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
ACTIVE_COMPARATOR: Manual chest wall vibration+ST; Manual chest wall vibration+Standard Therapy	Other: Standard Therapy; Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.; Other: Manual chest wall vibration; Five cycles of manual chest wall vibrations during 20 seconds each, being repeated five times. The manual chest wall vibrations are oscillatory maneuvers applied on the thorax to improve mucociliary clearance of bronchial mucus and ease its removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical score of respiratory distress	Wang clinical severity score	48 hours after baseline measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hours of supplementary oxygen		48 hours after baseline measurement
Peripheral blood oxygen level	Oxygen level or saturation is measured with a pulse oximeter	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Heart rate		Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Respiratory rate	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
wheezing	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Rib cage retractions	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
General clinical condition	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfer to high complexity unit	Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)	96 hours

Collaborators and Investigators

• Sponsor: Universidad del Desarrollo
• Collaborators: Hospital Padre Hurtado
• Investigators: Principal Investigator: Patricio Gomolán, Universidad del Desarrollo

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (ESTIMATE): August 3, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: chest physiotherapy; respiratory syncytial virus; acute viral bronchiolitis
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral
• Other Study ID Numbers: 2014-84

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be made available, If journal where report will be published requires to give access to individual patient data