Clinical trial NCT02853838: Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)
Official title: Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis, Viral
Keywords: acute viral bronchiolitis
respiratory syncytial virus
chest physiotherapy
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Hospital Padre Hurtado
First posted: 2016-08-03
Enrollment: 204
Sex: ALL
Minimum age (years): 15
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical score of respiratory distress
timeFrame: 48 hours after baseline measurement
Secondary outcomes:
measure: Hours of supplementary oxygen
timeFrame: 48 hours after baseline measurement
measure: Peripheral blood oxygen level
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
measure: Heart rate
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
measure: Respiratory rate
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
measure: wheezing
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
measure: Rib cage retractions
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
measure: General clinical condition
timeFrame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Other outcomes:
measure: Transfer to high complexity unit
timeFrame: 96 hours
Locations:
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
state: Región Metropolitana
Study officials:
affiliation: Universidad del Desarrollo
name: Patricio Gomolán
role: PRINCIPAL_INVESTIGATOR
References: