Bronchial AsthmaNCT03190759
Assessment of Asthma Exacerbation in Children by Modified Pulmonary Index Score
An observational study of Bronchial Asthma, run by Assiut University.
Trial summary
Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiatory airflow limitation. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2017to 20 Oct 2018
- 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 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: all patient admitted to emergency department of assiut university within three months of winter of anticipated number 60
Who may be able to join
- children with acute asthma exacerbation
- children with acute asthma aged 1-17 years old
- background history of asthma
- this study will deal with the protocols applied in Assiut university children hospital
Who cannot join
- children below age of 1 year and more than 17 years old
- Known Tuberculosis exposure
- concurrent stridor
- use of oral corticosteroids in the previous four weeks
- Significant co-morbid disease : lung ,cardiac ,immune , liver , endocrine ,neurological or psychiatric
- children with other causes of respiratory distress
- Children with mild or controlled asthma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Severity of Acute Asthma Exacerbation in Children Attending the Emergency Departments to Predict Outcomes by Modified Pulmonary Index Score
Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiatory airflow limitation. This definition was reached by consensus, based on consideration of the characteristics that are typical of asthma and that distinguish it from other respiratory conditions .
Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears that the global prevalence of asthma ranges from 1% to 18% of the population in different countries .
Read the detailed description
Over the past years, an increase in the number of emergency department (ED) visits for asthma exacerbation has been reported. Most of these visits are for preschool children.
Although pulmonary function tests are commonly used to assess the severity of acute asthma in adults, they are difficult to perform in children, especially those who are younger than five years old .
spirometry measures pulmonary markers such as vital capacity and maximal forced expiatory volume in 1 second. Well-trained personnel are required to perform these tests, and they are not routinely available in the ED. Peak flow has been used in the ED to measure the degree of respiratory obstruction .This technique is difficult to perform in children less than 6 years of age because of their lack of coordination and comprehension .
Adequate evaluation of the severity of asthma exacerbation is important for the initial management of patients, as well as for assessing the clinical response. However, severity is more difficult to assess in children. The clinical evaluation and physician's experience are often not enough to determine the degree of respiratory obstruction .
In the emergency room setting, the most critical issue facing the attending physician is, deciding the adequacy of outpatient therapy of acute asthma, or when hospitalization is indicated. Traditionally, this decision is used to be made according to the clinical history, physical examination, laboratory results and response to therapy of the patient .
A number of asthma severity measures or scoring systems have been established to estimate the degree of airway obstruction for children in whom the standard measurements cannot be performed. These systems combine a number of physical signs, such as respiratory rate and accessory muscle use, to form an aggregate score that estimates the severity of an acute asthma exacerbation .no scoring system is perfect, but some method of assessing severity in children is needed when spirometry testing is not obtainable.
modified the pulmonary index was reported by adding 2 scoring items, namely heart rate and SpO2 at room temperature, and by dividing the method of heart rate and respiratory rate scoring depending on which of 2 age groups the patient belong to. Modified Pulmonary Index Score is a quantitative method of evaluating respiratory conditions in asthmatic subjects modified and consists of 6 evaluation items, which are important for the assessment of dyspnea and are relatively easy to assess in clinical practice, namely heart rate, respiratory rate, accessory muscle use, inspiratory to expiatory flow ratio, degree of wheezing, and oxygen saturation in room air.
the predictive validity and reproducibility of the Modified Pulmonary Index Score for asthma exacerbation was reported in 30 children with a mean age of 7.6 ± 5.5 years in 2005. They found good correlations of the Modified Pulmonary Index Score with clinical outcomes such as ICU admission. The Modified Pulmonary Index Score appears to be suitable for measuring the severity of acute asthma exacerbation, and was applied as primary outcome measurement in some clinical trials .
A significant correlation between Modified Pulmonary Index Score at hospitalization and hospitalization period in children above 5 years old, suggesting that Modified Pulmonary Index Score was useful for predicting the clinical course after hospitalization. However, its applicability to preschool children has not yet been fully elucidated.
The Modified Pulmonary Index Score can be a useful tool for several aspects during acute asthma attacks, including the determination of a treatment plan, and prediction of the period of hospitalization in admitted patients .
- Conditions
- Bronchial Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU admission according to oxygen saturation <81%, respiratory rate <6years old = >60 ≥6years old = >50 and heart rate <3 years old = >160 ≥3 years old= >140
Adequate evaluation of the severity of asthma exacerbation is important for the initial management of patients,using clinical parameters to decide ICU admission :oxygen saturation ,heart rate,respiratory rate and Degree of agitation and conscious level.
Measured: within 15 minute
Secondary outcomes (1)
hospital stay
we will assess all patients with asthma by using parameters which included in modified pulmonary index score"namely heart rate, respiratory rate, accessory muscle use, inspiratory-to expiratory flow ratio, degree of wheezing, and oxygen saturation in room air." using score in predicting hospital stay
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start11 Nov 2017 (estimated)
- Primary completion22 Dec 2017 (estimated)
- Study completion20 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Heshmat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190759
- Sponsor's protocol ID
- asmpis
- Status last verified
- Jun 2017
- First submitted
- 10 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Becker AB, Nelson NA, Simons FE. The pulmonary index. Assessment of a clinical score for asthma. Am J Dis Child. 1984 Jun;138(6):574-6. doi: 10.1001/archpedi.1984.02140440058015.
PubMed 6720644Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.
PubMed 14709423Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
PubMed 15080825Smith SR, Baty JD, Hodge D 3rd. Validation of the pulmonary score: an asthma severity score for children. Acad Emerg Med. 2002 Feb;9(2):99-104. doi: 10.1111/j.1553-2712.2002.tb00223.x.
PubMed 11825832van der Windt D. Promises and pitfalls in the evaluation of pediatric asthma scores. J Pediatr. 2000 Dec;137(6):744-6. doi: 10.1067/mpd.2000.111458. No abstract available.
PubMed 11113827Weiss KB, Wagener DK. Changing patterns of asthma mortality. Identifying target populations at high risk. JAMA. 1990 Oct 3;264(13):1683-7.
PubMed 2398607
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Severity of Acute Asthma Exacerbation in Children Attending the Emergency Departments to Predict Outcomes by Modified Pulmonary Index Score
- ClinicalTrials.gov ID
- NCT03190759
- Acronym / sponsor ID
- asmpis
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Nov 2017 (estimated)
- Primary completion
- 22 Dec 2017 (estimated)
- Study completion
- 20 Oct 2018 (estimated)
- First posted
- 19 Jun 2017 (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.
Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiatory airflow limitation. This definition was reached by consensus, based on consideration of the characteristics that are typical of asthma and that distinguish it from other respiratory conditions .
Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears that the global prevalence of asthma ranges from 1% to 18% of the population in different countries .
Detailed description
Over the past years, an increase in the number of emergency department (ED) visits for asthma exacerbation has been reported. Most of these visits are for preschool children.
Although pulmonary function tests are commonly used to assess the severity of acute asthma in adults, they are difficult to perform in children, especially those who are younger than five years old .
spirometry measures pulmonary markers such as vital capacity and maximal forced expiatory volume in 1 second. Well-trained personnel are required to perform these tests, and they are not routinely available in the ED. Peak flow has been used in the ED to measure the degree of respiratory obstruction .This technique is difficult to perform in children less than 6 years of age because of their lack of coordination and comprehension .
Adequate evaluation of the severity of asthma exacerbation is important for the initial management of patients, as well as for assessing the clinical response. However, severity is more difficult to assess in children. The clinical evaluation and physician's experience are often not enough to determine the degree of respiratory obstruction .
In the emergency room setting, the most critical issue facing the attending physician is, deciding the adequacy of outpatient therapy of acute asthma, or when hospitalization is indicated. Traditionally, this decision is used to be made according to the clinical history, physical examination, laboratory results and response to therapy of the patient .
A number of asthma severity measures or scoring systems have been established to estimate the degree of airway obstruction for children in whom the standard measurements cannot be performed. These systems combine a number of physical signs, such as respiratory rate and accessory muscle use, to form an aggregate score that estimates the severity of an acute asthma exacerbation .no scoring system is perfect, but some method of assessing severity in children is needed when spirometry testing is not obtainable.
modified the pulmonary index was reported by adding 2 scoring items, namely heart rate and SpO2 at room temperature, and by dividing the method of heart rate and respiratory rate scoring depending on which of 2 age groups the patient belong to. Modified Pulmonary Index Score is a quantitative method of evaluating respiratory conditions in asthmatic subjects modified and consists of 6 evaluation items, which are important for the assessment of dyspnea and are relatively easy to assess in clinical practice, namely heart rate, respiratory rate, accessory muscle use, inspiratory to expiatory flow ratio, degree of wheezing, and oxygen saturation in room air.
the predictive validity and reproducibility of the Modified Pulmonary Index Score for asthma exacerbation was reported in 30 children with a mean age of 7.6 ± 5.5 years in 2005. They found good correlations of the Modified Pulmonary Index Score with clinical outcomes such as ICU admission. The Modified Pulmonary Index Score appears to be suitable for measuring the severity of acute asthma exacerbation, and was applied as primary outcome measurement in some clinical trials .
A significant correlation between Modified Pulmonary Index Score at hospitalization and hospitalization period in children above 5 years old, suggesting that Modified Pulmonary Index Score was useful for predicting the clinical course after hospitalization. However, its applicability to preschool children has not yet been fully elucidated.
The Modified Pulmonary Index Score can be a useful tool for several aspects during acute asthma attacks, including the determination of a treatment plan, and prediction of the period of hospitalization in admitted patients .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all patient admitted to emergency department of assiut university within three months of winter of anticipated number 60
Key inclusion criteria (4 listed)
- children with acute asthma exacerbation
- children with acute asthma aged 1-17 years old
- background history of asthma
- this study will deal with the protocols applied in Assiut university children hospital
Key exclusion criteria (7 listed)
- children below age of 1 year and more than 17 years old
- Known Tuberculosis exposure
- concurrent stridor
- use of oral corticosteroids in the previous four weeks
- Significant co-morbid disease : lung ,cardiac ,immune , liver , endocrine ,neurological or psychiatric
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU admission according to oxygen saturation <81%, respiratory rate <6years old = >60 ≥6years old = >50 and heart rate <3 years old = >160 ≥3 years old= >140
Time frame: within 15 minute
Adequate evaluation of the severity of asthma exacerbation is important for the initial management of patients,using clinical parameters to decide ICU admission :oxygen saturation ,heart rate,respiratory rate and Degree of agitation and conscious level.
1 secondary outcome
hospital stay
Time frame: within one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Results publication: PubMed 6720644Becker AB, Nelson NA, Simons FE. The pulmonary index. Assessment of a clinical score for asthma. Am J Dis Child. 1984 Jun;138(6):574-6. doi: 10.1001/archpedi.1984.02140440058015.
- Results publication: PubMed 14709423Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.
- Results publication: PubMed 15080825Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
- Results publication: PubMed 11825832Smith SR, Baty JD, Hodge D 3rd. Validation of the pulmonary score: an asthma severity score for children. Acad Emerg Med. 2002 Feb;9(2):99-104. doi: 10.1111/j.1553-2712.2002.tb00223.x.
- Results publication: PubMed 11113827van der Windt D. Promises and pitfalls in the evaluation of pediatric asthma scores. J Pediatr. 2000 Dec;137(6):744-6. doi: 10.1067/mpd.2000.111458. No abstract available.
- Results publication: PubMed 2398607Weiss KB, Wagener DK. Changing patterns of asthma mortality. Identifying target populations at high risk. JAMA. 1990 Oct 3;264(13):1683-7.
- Individual participant dataSharing planned: Yes
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Assiut University.
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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 . Moustafa El -Said, Professor (01110277000, moustafa13@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU admission according to oxygen saturation <81%, respiratory rate <6years old = >60 ≥6years old = >50 and heart rate <3 years old = >160 ≥3 years old= >140 (time frame: within 15 minute). 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 NCT03190759, which also lists 6 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 19 Jun 2017.