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

Primary Purpose

Bronchiolitis, Viral

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Prolonged slow expiration+provoked coughing
Manual chest wall vibration
Standard Therapy
Sponsored by
Universidad del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis, Viral focused on measuring acute viral bronchiolitis, respiratory syncytial virus, chest physiotherapy

Eligibility Criteria

15 Days - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Padre Hurtado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged slow expiration+provoked coughing+ST

Manual chest wall vibration+ST

Arm Description

Prolonged slow expiration+provoked coughing+Standard Therapy

Manual chest wall vibration+Standard Therapy

Outcomes

Primary Outcome Measures

Clinical score of respiratory distress
Wang clinical severity score

Secondary Outcome Measures

Hours of supplementary oxygen
Peripheral blood oxygen level
Oxygen level or saturation is measured with a pulse oximeter
Heart rate
Respiratory rate
Wang clinical severity score
wheezing
Wang clinical severity score
Rib cage retractions
Wang clinical severity score
General clinical condition
Wang clinical severity score

Full Information

First Posted
July 22, 2016
Last Updated
October 25, 2016
Sponsor
Universidad del Desarrollo
Collaborators
Hospital Padre Hurtado
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1. Study Identification

Unique Protocol Identification Number
NCT02853838
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Desarrollo
Collaborators
Hospital Padre Hurtado

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Viral
Keywords
acute viral bronchiolitis, respiratory syncytial virus, chest physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged slow expiration+provoked coughing+ST
Arm Type
Experimental
Arm Description
Prolonged slow expiration+provoked coughing+Standard Therapy
Arm Title
Manual chest wall vibration+ST
Arm Type
Active Comparator
Arm Description
Manual chest wall vibration+Standard Therapy
Intervention Type
Other
Intervention Name(s)
Prolonged slow expiration+provoked coughing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual chest wall vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Therapy
Intervention Description
Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
Primary Outcome Measure Information:
Title
Clinical score of respiratory distress
Description
Wang clinical severity score
Time Frame
48 hours after baseline measurement
Secondary Outcome Measure Information:
Title
Hours of supplementary oxygen
Time Frame
48 hours after baseline measurement
Title
Peripheral blood oxygen level
Description
Oxygen level or saturation is measured with a pulse oximeter
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Title
Heart rate
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Title
Respiratory rate
Description
Wang clinical severity score
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Title
wheezing
Description
Wang clinical severity score
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Title
Rib cage retractions
Description
Wang clinical severity score
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Title
General clinical condition
Description
Wang clinical severity score
Time Frame
Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Other Pre-specified Outcome Measures:
Title
Transfer to high complexity unit
Description
Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Days
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio Gomolán
Organizational Affiliation
Universidad del Desarrollo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Padre Hurtado
City
Santiago
State/Province
Región Metropolitana
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be made available, If journal where report will be published requires to give access to individual patient data

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

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