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

Bronchiolitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853838
• Other study ID #: 2014-84
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: October 25, 2016
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

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.
• 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.
• Standard Therapy
Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.

Locations

Country	Name	City	State
Chile	Hospital Padre Hurtado	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Hospital Padre Hurtado

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transfer to high complexity unit	Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)	96 hours	No
Primary	Clinical score of respiratory distress	Wang clinical severity score	48 hours after baseline measurement	No
Secondary	Hours of supplementary oxygen		48 hours after baseline measurement	No
Secondary	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.	No
Secondary	Heart rate		Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.	No
Secondary	Respiratory rate	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.	No
Secondary	wheezing	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.	No
Secondary	Rib cage retractions	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.	No
Secondary	General clinical condition	Wang clinical severity score	Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.	No