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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Universidad del Desarrollo

Current Primary Outcome: Clinical score of respiratory distress [ Time Frame: 48 hours after baseline measurement ]

Wang clinical severity score


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Universidad del Desarrollo

Dates:
Date Received: July 22, 2016
Date Started: March 2015
Date Completion:
Last Updated: October 25, 2016
Last Verified: October 2016