Acute Disease RespiratoryNCT04036591
Use Of The ABSS In Infants With ARIS Treated With Outpatient Respiratory Physiotherapy
An observational study of Acute Disease Respiratory, run by FisioRespiración at 1 site in Spain.
Trial summary
Background. Acute respiratory infections in childhood have high incidence and morbimortality rates, generating significant sanitary and social costs. Due to its diversity of manifestations and clinical forms, the degree of severity varies widely. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Acute Disease Respiratory
- What is being tested?
- Acute Bronchiolitis Severity Scale (ABSS)
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2019to May 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: All children who attend to FisioRespiración (Private respiratory physiotherapy unit in Madrid) to receive outpatient respiratory physiotherapy treatment and meet the inclusion/exclusion criteria will be selected until reaching the sample.
Who may be able to join
- Under 24 months
- ARIS diagnosed
- Medical indication of respiratory physiotherapy
- Evaluated during the first outpatient respiratory physiotherapy treatment
Who cannot join
- Chronic desease
- ABSS ≥ 7
- Temperature≥ 38ºC
- Stridor
- Expiratory groan
- Sternal sinking
- Any sign or symptom indicative of need for urgent medical evaluation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
FisioRespiración
Madrid, 28049
Beatriz Simón Rodríguez, 0034629441102, beatriz_simon@fisiorespiracion.es
About this study
Official title: Use Of The "Acute Bronchiolitis Severity Scale" In Infants With Acute Respiratory Infection Susceptible To Outpatient Respiratory PhysiotherapyTreatment
Background. Acute respiratory infections in childhood have high incidence and morbimortality rates, generating significant sanitary and social costs. Due to its diversity of manifestations and clinical forms, the degree of severity varies widely.
Published acute respiratory infections assessment severity scales are mainly focused on acute bronchiolitis, but there is no validated scale to evaluate the effects of respiratory physiotherapy in acute respiratory infections in children.
Read more
Objective. To study the usefulness of the Acute Bronchiolitis Severity Scale to assess children under 24 months suffering from acute respiratory infections susceptible to receive outpatient respiratory physiotherapy treatment.
Methods. Pre-post assessment descriptive study using the Acute Bronchiolitis Severity Scale. Children under 24 months suffering from acute respiratory infection will be evaluated during the first outpatient respiratory physiotherapy treatment.
- Conditions
- Acute Disease Respiratory
- Being tested
- Acute Bronchiolitis Severity Scale (ABSS)
- Keywords
- Clinical scale, infant, respiratory therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Bronchiolitis Severity Scale (ABSS)Diagnostic test
Also called Chest Physiotherapy
All infants will be assessed using the Acute Bronchiolitis Severity Scale (ABSS) before and after being treated by experienced physiotherapists using the prolonged slow expiration technique and provoqued cough. Before the application of these techniques a retrograde rhinopharyngeal unclogging will be performed in order to clean the nasopharynx.
| Study group | Role | What they receive |
|---|---|---|
| Children under 24 months with ARIS | Not described Receives: Diagnostic Test: Acute Bronchiolitis Severity Scale (ABSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness of Acute Bronchiolitis Severity Score (ABSS) to asses children under 24 months suffering from acute respiratory infection susceptible to receive outpatient respiratory physiotherapy treatment.
Physiotherapists will use the Acute Bronchiolitis Severity Score (ABSS) to assess severity of infection pre and post treatment. After several assessments each one of them will inform about the usefulness and aplicability of the scale in outpatient respiratory physiotherapy treatment by filling in a likert scale (usefulness, aplicability, simplicity, time required...)
Measured: Through study completion, an average of 2 years.
Immediate effectiveness of outpatient respiratory physiotherapy treatment.
Change from baseline in the Acute Bronchiolitis Severity Score (ABSS) punctuation at the end of outpatient respiratory physiotherapy treatment (pre-post treatment measurement of the scale).
The ABSS is a validated scale in a Spanish population that combines the evaluation of heart and respiratory rate, wheezings, crackles, respiratory effort and inspiration/exhalation ratio. It has three levels of severity: mild (0 to 4 points), moderate (5 to 9) and severe (10 to 13).
Measured: Measurements will be taken during the outpatient respiratory physiotherapy treatment, 1 hour approximately. Pre treatment data will be collected before starting the treatment and post data 5 minutes after finishing the last manouver.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start26 Feb 2019
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Disease RespiratoryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- FisioRespiración
- Sponsor type
- University, hospital or other
- Collaborators
- Neumomadrid, Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Beatriz Simón Rodríguez, FisioRespiración
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036591
- Sponsor's protocol ID
- 19/058-E_TFM
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of The "Acute Bronchiolitis Severity Scale" In Infants With Acute Respiratory Infection Susceptible To Outpatient Respiratory PhysiotherapyTreatment
- ClinicalTrials.gov ID
- NCT04036591
- Acronym / sponsor ID
- 19/058-E_TFM
- Conditions
- Acute Disease Respiratory
- Keywords
- Clinical scale, infant, respiratory therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- FisioRespiraciónUniversity, hospital or other
- Collaborators
- Neumomadrid, Universidad Complutense de Madrid
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 30 Jul 2019 (actual)
- 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.
Background. Acute respiratory infections in childhood have high incidence and morbimortality rates, generating significant sanitary and social costs. Due to its diversity of manifestations and clinical forms, the degree of severity varies widely.
Published acute respiratory infections assessment severity scales are mainly focused on acute bronchiolitis, but there is no validated scale to evaluate the effects of respiratory physiotherapy in acute respiratory infections in children.
Objective. To study the usefulness of the Acute Bronchiolitis Severity Scale to assess children under 24 months suffering from acute respiratory infections susceptible to receive outpatient respiratory physiotherapy treatment.
Methods. Pre-post assessment descriptive study using the Acute Bronchiolitis Severity Scale. Children under 24 months suffering from acute respiratory infection will be evaluated during the first outpatient respiratory physiotherapy treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children under 24 months with ARIS | – | Diagnostic Test: Acute Bronchiolitis Severity Scale (ABSS) |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children who attend to FisioRespiración (Private respiratory physiotherapy unit in Madrid) to receive outpatient respiratory physiotherapy treatment and meet the inclusion/exclusion criteria will be selected until reaching the sample.
Key inclusion criteria (4 listed)
- Under 24 months
- ARIS diagnosed
- Medical indication of respiratory physiotherapy
- Evaluated during the first outpatient respiratory physiotherapy treatment
Key exclusion criteria (7 listed)
- Chronic desease
- ABSS ≥ 7
- Temperature≥ 38ºC
- Stridor
- Expiratory groan
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 |
|---|---|---|
| Acute Bronchiolitis Severity Scale (ABSS)Also: Chest PhysiotherapyAll infants will be assessed using the Acute Bronchiolitis Severity Scale (ABSS) before and after being treated by experienced physiotherapists using the prolonged slow expiration technique and provoqued cough. Before the application of these techniques a retrograde rhinopharyngeal unclogging will be performed in order to clean the nasopharynx. | Diagnostic test | Children under 24 months with ARIS |
Primary outcome
Usefulness of Acute Bronchiolitis Severity Score (ABSS) to asses children under 24 months suffering from acute respiratory infection susceptible to receive outpatient respiratory physiotherapy treatment.
Time frame: Through study completion, an average of 2 years.
Physiotherapists will use the Acute Bronchiolitis Severity Score (ABSS) to assess severity of infection pre and post treatment. After several assessments each one of them will inform about the usefulness and aplicability of the scale in outpatient respiratory physiotherapy treatment by filling in a likert scale (usefulness, aplicability, simplicity, time required...)
Immediate effectiveness of outpatient respiratory physiotherapy treatment.
Time frame: Measurements will be taken during the outpatient respiratory physiotherapy treatment, 1 hour approximately. Pre treatment data will be collected before starting the treatment and post data 5 minutes after finishing the last manouver.
Change from baseline in the Acute Bronchiolitis Severity Score (ABSS) punctuation at the end of outpatient respiratory physiotherapy treatment (pre-post treatment measurement of the scale). The ABSS is a validated scale in a Spanish population that combines the evaluation of heart and respiratory rate, wheezings, crackles, respiratory effort and inspiration/exhalation ratio. It has three levels of severity: mild (0 to 4 points), moderate (5 to 9) and severe (10 to 13).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Disease Respiratory, run by FisioRespiración at 1 site in Spain.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Simón Rodríguez (0034629441102, beatriz_simon@fisiorespiracion.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness of Acute Bronchiolitis Severity Score (ABSS) to asses children under 24 months suffering from acute respiratory infection susceptible to receive outpatient respiratory physiotherapy treatment. (time frame: Through study completion, an average of 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.