Download 7.6 Has the ethical clearance obtained from your institution

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA , BENGALURU
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1
Name of the Candidate and
Address(in block letters)
DR CHAITRA RAO B
#379 SURABHI,NEAR HEAD POST
OFFICE
CHIKKENSAL ROAD KUNDAPURA
UDUPI-576201
2
Name of the Institution
Kempegowda Institute of Medical
Sciences and Research Centre, Bengaluru
3
Course of Study and Subject
M.D. Paediatrics
4
Date of Admission to the Course
30/05/2011
5
Title of the Topic
Study of peak expiratory flow rate and
pulmonary score in the evaluation of acute
exacerbation of asthma in the age group of
5-18 years.
6 Brief resume of the intended work
6.1 Need for the Study
Asthma is a problem worldwide, with an estimated 200 million affected children with mortality of
0.2 million per year. Evidence from the ISAAC study also showed that the distribution of
Childhood Bronchial Asthma varied between global populations from less than 2% to
approximately 33%. Prevalence reached 17 – 30% in the UK, New Zealand, and Australia,
whereas, areas of low prevalence (1 – 7%) include Eastern Europe, China, and Indonesia.
Susceptibility to the development of asthma depends on the interaction of multiple genes, coupled
with environmental exposures. Understanding the precise role of environmental exposures in the
development of asthma is absolutely critical to reducing the burden of this disease in children.
Asthma is an inflammatory disorder of the airways characterized by variable airflow obstruction
and airway hyperresponsiveness to a variety of stimuli.
Accurate measurement of the severity of an acute asthma exacerbation is important to guide initial
treatment and to monitor response to subsequent therapy. The most accurate method to measure
severity is spirometry, in which a number of pulmonary functions such as forced vital capacity and
forced expiratory volume in 1 second are measured. Unfortunately, spirometry requires special
equipment not often available in the emergency department, as well as staff trained to perform and
interpret the results. However, spirometry and peak expiratory flow rate are difficult methods for
younger children to perform, or children of any age with severe obstruction.
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.
Although more than 16 severity scoring systems exist, many are difficult to use. For example,
some severity measures require blood gas analyses; others require numerous objective measures, or
demanding assessments such as inspiratory/expiratory ratios.
The pulmonary score was developed to provide a ‘‘user-friendly’’ measure of asthma severity for
children with an acute asthma exacerbation.
The purpose of this study was to validate the pulmonary score as a measure of airway obstruction
in children presenting to the emergency department for treatment of an acute asthma exacerbation.
6.2 Review of literature
Asthma is a chronic inflammatory disorder of the airways associated with airway
hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness
and coughing, particularly at night or in the early morning. These episodes are usually associated
with widespread, but variable airflow obstruction within the lung that is often reversible either
spontaneously or with treatment.(8)
Acute exacerbations of asthma are episodes of progressive increase in shortness of breath,
cough, wheezing or chest tightness or combination of these symptoms characterised by decrease in
expiratory flow that can be quantified and monitored by measurement of lung function.(8)
Peak expiratory flow provided a simple quantitative and reproducible measure of resistance
and severity of airflow obstruction. Peak expiratory flow can be measured with inexpensive and
portable peak expiratory flow meter. Peak flow monitoring can be used for short term monitoring,
managing exacerbations and daily long term monitoring.(7)
Taman et all conducted a clinical study to compare between both paediatric asthma severity
score and pulmonary score as clinical tools to others instrumental measures as peak flow meter,
pulse oximetry and arterial blood gases for assessing the severity of acute asthmatic attacks in
children and also to find if clinical assessment tools are of value for rapid intervention in treatment
of acute asthma, compared to laboratory measurements. This clinical study was done on 100
ashthmatic children presenting with acute attacks of asthma. Their age ranged from 5-16 years
during the period from January 2005 to January 2006. There was significant association between
paediatric asthma severity score and peak expiratory flow rate before treatment, 20 minutes and 24
hours after treatment. There was also significant association between pulmonary score and peak
expiratory flow rate before treatment, 20 minutes and 24 hours after treatment. Conclusion:
Paediatric asthma severity score and pulmonary score are of clinical utility in assessing the severity
of asthmatic attacks especially if the patient is unable to use the peak flow meter or when pulse
oximetry or the peak flow meter are not available (1)
Sharon R Smith et all conducted a clinical study which enrolled a convenience sample of
children, aged 5-17 years, who came to the emergency department for treatment of an acute asthma
exacerbation. The purpose of this study was to begin validation trials of the pulmonary score by
comparing it with the peak expiratory flow rate. The peak expiratory flow rate and the pulmonary
score were measured before and after the first albuterol treatment by a physician and a nurse from
a pool of 45 trained observers. The pulmonary score includes respiratory rate, wheezing, and
retractions, each rated on a 0-3 scale. Pre- and post-treatment peak expiratory flow rate and
pulmonary score were compared using paired t-tests to establish construct validity. Correlation of
pre- and post-treatment pulmonary score with peak expiratory flow rate was measured to establish
criterion validity.
Conclusions: This study support the construct and criterion validities of the pulmonary score as a
measure of asthma severity among children.(2)
Katie Sabato RRI et all conducted a study with the objective to develop a clinical asthma
score for use in hospitalized children between 1 and 5 years of age. The final clinical asthma score
consisted of five clinical characteristics: respiratory rate, wheezing, indrawing, observed dyspnoea,
and inspiratory-to-expiratory ratio. The clinical asthma score was valid, with a strong correlation
with length of hospital stay and drug dosing interval. Conclusion: This score, for use in
hospitalized preschool children, is reliable, discriminatory, valid, and responsive.(3)
Browne G et all conducted a study which used a clinical score, the pulmonary index, in the
emergency room assessment of children with acute asthma. The pulmonary index was derived
from respiratory rate, wheezing, inspiratory-expiratory ratio, and use of accessory muscles. The
pulmonary index before treatment correlated significantly with the mean percent of forced
expiratory volume in the first second to forced vital capacity ratio. The pulmonary index 30
minutes after treatment correlated significantly with all tests of pulmonary function performed. The
PI is a simple score that is easily derived from clinical observation.(4)
6.3 OBJECTIVES OF THE STUDY


To study the efficacy of pulmonary score in assessing the severity of acute exacerbation of
asthma in comparison to peak expiratory flow rate.
To compare pulmonary score with peak expiratory flow rate in measuring the outcome of
management of acute exacerbation of asthma.
7. MATERIALS AND METHODS
7.1 SOURCE OF THE DATA
a)
b)
c)
d)
Study design : Comparative study
Sample size :50
Study place : Department of paediatrics, KIMS Hospital, Bengaluru
Study period : December 2011 to May 2013
7.2 METHOD OF COLLECTION OF DATA
Children in the age group of 5-18 years presenting to the paediatric department-both
outpatient and inpatient with acute exacerbation of asthma are the subjects for the study.
Peak expiratory flow rate and pulmonary score is assessed initially before starting
treatment. The instrument used to measure peak expiratory flow rate is Mini-Wright
peak flow meters by Clement Clarke. The highest of the three readings is used as the
recorded value of peak expiratory flow rate. Formula used to calculate normal PEFR
value-(Height-100)*5+100.(7)
Peak expiratory flow rate of the patient is expressed as percentage of normal peak
expiratory flow rate .
Pulmonary score is assessed by 3 variables: respiratory rate, wheezing and use of
accessory muscles, each variable is awarded 4 scores-0,1,2,3,totally summed upto 9.(2)
Table 1
SCORE
0
1
RESPIRATORY
RATE
<20
21-35
2
36-50
3
>50
WHEEZE
USE OF ACCESSORY MUSCLE
None
Terminal
expiration
with
stethoscope
Entire
expiration
with
stethoscope
Inspiration
and
expiration
without
stethoscope
No retraction
Subcoastal/intercoastal retraction
Subcoastal/intercoastal+suprasternal
retraction
Use of ala nasi
Treatment started according to the standard protocol of asthma management. Peak
expiratory flow rate and Pulmonary score is again assessed immediately after starting first
dose of bronchodilator therapy, at 5 minutes, at 10 minutes, at 15 minutes and at the time of
disposition.
The results obtained are subjected to statistical analysis-Correlation and regression.
7.3 INCLUSION CRITERIA
1. Children in the age group of 5-18 years presenting to the paediatric department with
acute exacerbation of asthma .
2. Parents willing to give signed informed consent.
7.4 EXCLUSION CRITERIA
1. Coexistent immunosuppressive, cardiac and neurological condition affecting
pulmonary function or other chronic pulmonary disease.
2. Children who are not able to perform peak expiratory flow rate.
7.5 Does the study require any investigation or interventions to be conducted on
patients or other human or animals? If so, please describe briefly.
No
7.6 Has the ethical clearance obtained from your institution for this study and
required investigations in this study?
Yes.
8. List of references
1. Taman, Khaled; Shaheen, Malak; Mokhtar, Lammia. Paediatric asthma severity score "PASS"
and pulmonary score "PS" as clinical tools compared to others instrumental measures in acute
asthmatic children. World allergy organisation journal: Nov 2007: pS119
2. Sharon R Smith, MD, Jack D Baty, BA, Dee Hodge, 111, MD: validation of the pulmonary
score: an asthma severity score for children. Academic emergency medicine, Feb 2002, vol 9,
no 2, 99-104.
3. Katie Sabato RRT, MS, Perry Picchi, RRT,Jeanette Asselin RRT, MS, Mary Rutherford
MD, Children Hospital Oakland, Oakland California. Use of a Clinical Asthma Score (CAS)
as the Initial Step in an Asthma Treatment Algorithm in a Paediatric Emergency Department.
The Science Journal of the American Association for Respiratory Care:2002
4. Hsu P, Lam LT, Browne G. The pulmonary index score as a clinical assessment tool for acute
childhood asthma. Annual Allergy Asthma Immunology. 2010 Dec;105(6):425-9
5. Becker A B, Nelson M A, Simons E R. The pulmonary index assessment of a clinical score for
asthma. Am J Dis Child1984,138:574-576
6. Yung M, South M, Byrt T. Evaluation of an asthma severity score: journal of Paediatric child
health,1996:32:261-264
7. S. Balasubramanian, N.R. Ravikumar, Elavazhagan Chakkarapani, S.O. Shivbalan: Peak
Expiratory Flow Rate in Children - A Ready Reckoner, Indian Paediatrics 2002; 39: 104-106
8. Global strategy for asthma management and control-2010 update
9. Marc H. Gorelick, MD, MSCE, Molly W. Stevens, MD, Theresa R. Schultz, RRT, RN,Philip
V. Scribano, DO, MSCE: Performance of a Novel Clinical Score, the Paediatric Asthma
Severity Score, in the Evaluation of Acute Asthma.
10. Chalut DS, Ducharme FM, Davis GM. The Preschool Respiratory Assessment Measure
(PRAM): a responsive index of acute asthma severity. J Pediatr. 2000; 137:762–8.
9.Signature of the candidate
10.Remarks of the guide
As acute exacerbation of asthma is prevalent
among paediatric age group and it is an
emergency condition, assessing the severity
is very important. So pulmonary score helps
in assessing such situations when peak
expiratory flow rate is difficult to perform.
11.Name and Designation of:
11.1 Guide
Dr Chandrakala . P,MBBS,MD
Associate Professor, Department of
Paediatrics, Kempegowda Institute of
Medical Sciences, Bengaluru
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of the Department
11.6 Signature
12.1 Remarks of the Chairman and
Principal
12.2 Signature
Dr. A C Ramesh, MBBS,MD,DCH
Professor and Head,
Department of Paediatrics, Kempegowda
Institute of Medical Sciences, Bengaluru