Bronchiolitis, ViralNCT02853838
Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)
A study testing Prolonged slow expiration+provoked coughing, Manual chest wall vibration and Standard Therapy in people with Bronchiolitis, Viral, run by Universidad del Desarrollo at 1 site in Chile.
Trial 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 (+). Read more about this study
- Who is it for?
- Ages 15 days to 12 months
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- Prolonged slow expiration+provoked coughing, Manual chest wall vibration and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChile
- Study dates
- Mar 2015to Oct 2016
- 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 15 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of bronchiolitis.
- RSV positive in direct immunofluorescence assay.
- Wang clinical severity score ≥ 4 points.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial
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.
Read the 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.
- Conditions
- Bronchiolitis, Viral
- Being tested
- Prolonged slow expiration+provoked coughing, Manual chest wall vibration, Standard Therapy
- Keywords
- acute viral bronchiolitis, respiratory syncytial virus, 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.
Prolonged slow expiration+provoked coughingOther
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 vibrationOther
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 TherapyOther
Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged slow expiration+provoked coughing+ST | Experimental | Prolonged slow expiration+provoked coughing+Standard Therapy Receives: Other: Prolonged slow expiration+provoked coughing; Other: Standard Therapy |
| Manual chest wall vibration+ST | Active comparator | Manual chest wall vibration+Standard Therapy Receives: Other: Manual chest wall vibration; Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical score of respiratory distress
Wang clinical severity score
Measured: 48 hours after baseline measurement
Secondary outcomes (7)
Hours of supplementary oxygen
Measured: 48 hours after baseline measurement
Peripheral blood oxygen level
Oxygen level or saturation is measured with a pulse oximeter
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Heart rate
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Respiratory rate
Wang clinical severity score
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
wheezing
Wang clinical severity score
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Rib cage retractions
Wang clinical severity score
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
General clinical condition
Wang clinical severity score
Measured: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis, ViralStudies 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
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Padre Hurtado
- Responsible party
- Principal investigator, Patricio Gomolan Gonzalez, Universidad del Desarrollo
- Investigators
- Patricio Gomolán, Principal investigator, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853838
- Sponsor's protocol ID
- 2014-84
- Status last verified
- Oct 2016
- First submitted
- 22 Jul 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data will be made available, If journal where report will be published requires to give access to individual patient data
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 37010196
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial
- ClinicalTrials.gov ID
- NCT02853838
- Acronym / sponsor ID
- 2014-84
- Conditions
- Bronchiolitis, Viral
- Keywords
- acute viral bronchiolitis, respiratory syncytial virus, chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Hospital Padre Hurtado
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Aug 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged slow expiration+provoked coughing+ST | Experimental | Other: Prolonged slow expiration+provoked coughing, Other: Standard TherapyProlonged slow expiration+provoked coughing+Standard Therapy |
| Manual chest wall vibration+ST | Active comparator | Other: Manual chest wall vibration, Other: Standard TherapyManual chest wall vibration+Standard Therapy |
Who may qualify
- Ages
- 15 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of bronchiolitis.
- RSV positive in direct immunofluorescence assay.
- Wang clinical severity score ≥ 4 points.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| Prolonged slow expiration+provoked coughingFive 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 | Prolonged slow expiration+provoked coughing+ST |
| Manual chest wall vibrationFive 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 | Manual chest wall vibration+ST |
| Standard TherapyStandard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy. | Other | Manual chest wall vibration+ST, Prolonged slow expiration+provoked coughing+ST |
Primary outcome
Clinical score of respiratory distress
Time frame: 48 hours after baseline measurement
Wang clinical severity score
7 secondary outcomes
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.
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.
wheezing
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Rib cage retractions
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
General clinical condition
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
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 26 Oct 2016.
- 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.
- Individual participant dataSharing planned: Undecided. Data will be made available, If journal where report will be published requires to give access to individual patient data
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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.
Patricio Gomolán principal investigator
Universidad del Desarrollo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged slow expiration+provoked coughing, Manual chest wall vibration and Standard Therapy in people with Bronchiolitis, Viral, run by Universidad del Desarrollo at 1 site in Chile.
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 3 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 26 Oct 2016. 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 Chile. 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?
Clinical score of respiratory distress (time frame: 48 hours after baseline measurement). 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 NCT02853838, which also lists 1 linked publication.
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 26 Oct 2016.