Viral BronchiolitisECPAVBNCT00884429
Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis
A study testing Chest physiotherapy - Conventional, Chest physiotherapy - actual techniques and 3-Airway suction in people with Viral Bronchiolitis, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 24 months
- Conditions the study is for
- Viral Bronchiolitis
- What is being tested?
- Chest physiotherapy - Conventional, Chest physiotherapy - actual techniques and 3-Airway suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of acute viral bronchiolitis
- RSV positive
Who cannot join
- Heart diseases
- Chronic lung disease
- Neurological diseases
- Parental refusal
- Previous wheezing episode
- ventilatory support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Chest Physiotherapy Actual Versus Conventional Techniques in Infants With Acute Viral Bronchiolitis. Random Clinical Trial
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.
Read the 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.
- Conditions
- Viral Bronchiolitis
- Being tested
- Chest physiotherapy - Conventional, Chest physiotherapy - actual techniques, 3-Airway suction
- Keywords
- Chest physiotherapy
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy - ConventionalProcedure or surgery
Percussion Postural Drainage and thorax compression
Chest physiotherapy - actual techniquesProcedure or surgery
Slow prolonged expiration and clearance rhinopharynx retrograde
3-Airway suctionProcedure or surgery
Airway suction
| Study group | Role | What they receive |
|---|---|---|
| 1- Conventional Chest Physiotherapy | Active comparator | Percussion , thorax compression and Postural Drainage/suction if necessary Receives: Procedure: Chest physiotherapy - Conventional |
| 2- Chest physiotherapy- Actual techniques | Active comparator | slow prolonged expiration and clearance rhinopharynx and suction if necessary Receives: Procedure: Chest physiotherapy - actual techniques |
| 3- Airway Suction | Active comparator | Suction superior airways. Only in admission. Receives: Procedure: 3-Airway suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory distress
This outcome was evaluated with Wang's score for infants with bronchiolitis
Measured: on first evaluation by physiotherapyst ( until 2 hours after hospital admission)
Secondary outcomes (3)
Respiratory distress
Wang's score
Measured: 48 hours after first evaluation
Respiratory distress
Wang's score
Measured: 72 hours after first evaluation
Respiratory distress
wang's score
Measured: 1 hour before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Viral BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelim Leal de Freitas Dantas Gomes, Hospital Sirio-Libanes
- Investigators
- Evelim LF Dantas Gomes, Master, Principal investigator, Hospital Sírio Libanês e UNINOVE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884429
- Sponsor's protocol ID
- BHSL
- Acronym
- ECPAVB
- Status last verified
- Jan 2012
- First submitted
- 17 Apr 2009
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37010196Gomes 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.
PubMed 22499404
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chest Physiotherapy Actual Versus Conventional Techniques in Infants With Acute Viral Bronchiolitis. Random Clinical Trial
- ClinicalTrials.gov ID
- NCT00884429
- Acronym / sponsor ID
- ECPAVB / BHSL
- Conditions
- Viral Bronchiolitis
- Keywords
- Chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- Conventional Chest Physiotherapy | Active comparator | Procedure: Chest physiotherapy - ConventionalPercussion , thorax compression and Postural Drainage/suction if necessary |
| 2- Chest physiotherapy- Actual techniques | Active comparator | Procedure: Chest physiotherapy - actual techniquesslow prolonged expiration and clearance rhinopharynx and suction if necessary |
| 3- Airway Suction | Active comparator | Procedure: 3-Airway suctionSuction superior airways. Only in admission. |
Who may qualify
- Ages
- 28 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute viral bronchiolitis
- RSV positive
Key exclusion criteria (6 listed)
- Heart diseases
- Chronic lung disease
- Neurological diseases
- Parental refusal
- Previous wheezing episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest physiotherapy - ConventionalPercussion Postural Drainage and thorax compression | Procedure or surgery | 1- Conventional Chest Physiotherapy |
| Chest physiotherapy - actual techniquesSlow prolonged expiration and clearance rhinopharynx retrograde | Procedure or surgery | 2- Chest physiotherapy- Actual techniques |
| 3-Airway suctionAirway suction | Procedure or surgery | 3- Airway Suction |
Primary outcome
Respiratory distress
Time frame: on first evaluation by physiotherapyst ( until 2 hours after hospital admission)
This outcome was evaluated with Wang's score for infants with bronchiolitis
3 secondary outcomes
Respiratory distress
Time frame: 48 hours after first evaluation
Respiratory distress
Time frame: 72 hours after first evaluation
Respiratory distress
Time frame: 1 hour before hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Derived from this study: PubMed 37010196Roque-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.
- Derived from this study: PubMed 22499404Gomes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelim LF Dantas Gomes, Master principal investigator
Hospital Sírio Libanês e UNINOVE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy - Conventional, Chest physiotherapy - actual techniques and 3-Airway suction in people with Viral Bronchiolitis, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory distress (time frame: on first evaluation by physiotherapyst ( until 2 hours after hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.