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Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis (ECPAVB)

Primary Purpose

Viral Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Chest physiotherapy - Conventional
Chest physiotherapy - actual techniques
3-Airway suction
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Bronchiolitis focused on measuring Chest physiotherapy

Eligibility Criteria

28 Days - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of acute viral bronchiolitis
  • RSV positive

Exclusion Criteria:

  • Heart diseases
  • Chronic lung disease
  • Neurological diseases
  • Parental refusal
  • Previous wheezing episode
  • ventilatory support

Sites / Locations

  • Hospital Sírio Libanês

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1- Conventional Chest Physiotherapy

2- Chest physiotherapy- Actual techniques

3- Airway Suction

Arm Description

Percussion , thorax compression and Postural Drainage/suction if necessary

slow prolonged expiration and clearance rhinopharynx and suction if necessary

Suction superior airways. Only in admission.

Outcomes

Primary Outcome Measures

Respiratory distress
This outcome was evaluated with Wang's score for infants with bronchiolitis

Secondary Outcome Measures

Respiratory distress
Wang's score
Respiratory distress
Wang's score
Respiratory distress
wang's score

Full Information

First Posted
April 17, 2009
Last Updated
August 28, 2012
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT00884429
Brief Title
Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis
Acronym
ECPAVB
Official Title
Effectiveness of Chest Physiotherapy Actual Versus Conventional Techniques in Infants With Acute Viral Bronchiolitis. Random Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to verify the effectiveness of chest physiotherapy (actual versus conventional) on respiratory distress in infants with acute viral bronchiolitis.
Detailed Description
The infants were random in three groups: Conventional techniques, actual techniques and suction of upper airways On the first two groups the infants were evaluated on admission,48,72hours and before hospital discharge. On third group was evaluated only on admission when SRV was collected. Respiratory distress was evaluated with Wang's score by the physiotherapists and nurses not participating in the research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Bronchiolitis
Keywords
Chest physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1- Conventional Chest Physiotherapy
Arm Type
Active Comparator
Arm Description
Percussion , thorax compression and Postural Drainage/suction if necessary
Arm Title
2- Chest physiotherapy- Actual techniques
Arm Type
Active Comparator
Arm Description
slow prolonged expiration and clearance rhinopharynx and suction if necessary
Arm Title
3- Airway Suction
Arm Type
Active Comparator
Arm Description
Suction superior airways. Only in admission.
Intervention Type
Procedure
Intervention Name(s)
Chest physiotherapy - Conventional
Intervention Description
Percussion Postural Drainage and thorax compression
Intervention Type
Procedure
Intervention Name(s)
Chest physiotherapy - actual techniques
Intervention Description
Slow prolonged expiration and clearance rhinopharynx retrograde
Intervention Type
Procedure
Intervention Name(s)
3-Airway suction
Intervention Description
Airway suction
Primary Outcome Measure Information:
Title
Respiratory distress
Description
This outcome was evaluated with Wang's score for infants with bronchiolitis
Time Frame
on first evaluation by physiotherapyst ( until 2 hours after hospital admission)
Secondary Outcome Measure Information:
Title
Respiratory distress
Description
Wang's score
Time Frame
48 hours after first evaluation
Title
Respiratory distress
Description
Wang's score
Time Frame
72 hours after first evaluation
Title
Respiratory distress
Description
wang's score
Time Frame
1 hour before hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of acute viral bronchiolitis RSV positive Exclusion Criteria: Heart diseases Chronic lung disease Neurological diseases Parental refusal Previous wheezing episode ventilatory support
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelim LF Dantas Gomes, Master
Organizational Affiliation
Hospital Sírio Libanês e UNINOVE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22499404
Citation
Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
Results Reference
derived

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Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis

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