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

This study has been completed.
Sponsor:
Collaborator:
Hospital Padre Hurtado
Information provided by (Responsible Party):
Patricio Gomolan Gonzalez, Universidad del Desarrollo
ClinicalTrials.gov Identifier:
NCT02853838
First received: July 22, 2016
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Bronchiolitis, Viral
Other: Prolonged slow expiration+provoked coughing
Other: Manual chest wall vibration
Other: Standard Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial

Further study details as provided by Universidad del Desarrollo:

Primary Outcome Measures:
  • Clinical score of respiratory distress [ Time Frame: 48 hours after baseline measurement ]
    Wang clinical severity score


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Transfer to high complexity unit [ Time Frame: 96 hours ]
    Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)


Enrollment: 204
Study Start Date: March 2015
Study Completion Date: October 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.

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

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

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02853838

Locations
Chile
Hospital Padre Hurtado
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
Universidad del Desarrollo
Hospital Padre Hurtado
Investigators
Principal Investigator: Patricio Gomolán Universidad del Desarrollo
  More Information

Responsible Party: Patricio Gomolan Gonzalez, Lecturer, Universidad del Desarrollo
ClinicalTrials.gov Identifier: NCT02853838     History of Changes
Other Study ID Numbers: 2014-84
Study First Received: July 22, 2016
Last Updated: October 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Data will be made available, If journal where report will be published requires to give access to individual patient data

Keywords provided by Universidad del Desarrollo:
acute viral bronchiolitis
respiratory syncytial virus
chest physiotherapy

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 25, 2017