Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)
NCT ID: NCT02853838
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2015-03-31
2016-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Prolonged slow expiration+provoked coughing+ST
Prolonged slow expiration+provoked coughing+Standard Therapy
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.
Standard Therapy
Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
Manual chest wall vibration+ST
Manual chest wall vibration+Standard Therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* RSV positive in direct immunofluorescence assay.
* Wang clinical severity score ≥ 4 points.
Exclusion Criteria
* 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.
15 Days
12 Months
ALL
No
Sponsors
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Hospital Padre Hurtado
OTHER
Universidad del Desarrollo
OTHER
Responsible Party
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Patricio Gomolan Gonzalez
Lecturer
Principal Investigators
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Patricio Gomolán
Role: PRINCIPAL_INVESTIGATOR
Universidad del Desarrollo
Locations
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Hospital Padre Hurtado
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
Other Identifiers
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2014-84
Identifier Type: -
Identifier Source: org_study_id