Aims & Objectives:
The aims and objectives of this study are-
Primary objectives:
For the patients admitted to a tertiary care Pediatric
Intensive Care Unit (PICU) with a respiratory illness, to determine the --
1. Etiology of the respiratory
illness
2. Indication for
admission to the PICU
3. Final outcome
(survival/death)
4. Predictors of
mortality
Secondary Objectives:
For the patients admitted to a tertiary care Pediatric
Intensive Care Unit (PICU) with a respiratory illness, to determine the --
1. Co-morbidities
2. Complications
3. Need for
mechanical ventilation (non-invasive/invasive) & duration of the
ventilation. Materials & Methods:
Ethics: The
study will be initiated after seeking approval from the “Institutional Ethics
Committee (IEC)†of the hospital. The study will be conducted in compliance
with the “Ethical Guidelines for Biomedical Research on Human Participants†by
the Indian Council of Medical Research.
Consent & Assent:
Case enrollment will be done after a written informed consent
from the parent/ guardian. Since patients in the PICU are critically ill, the
assent will be procured from children aged 7 years and above once the clinical
condition stabilizes and when they are in a position to give the assent.
Study design:
Prospective, non-interventional, observational, single centre study.
Study duration: The
study will be conducted over a period of 12 months (prospectively) after approval
from the IEC. Each patient will be in the study till his/her stay in the PICU.
Study site:
The study will be conducted in patients admitted to the PICU of KEM hospital,
Mumbai, which is a tertiary care, 14-bedded PICU with state-of-art facilities
including mechanical ventilators, non-invasive monitors and other devices for
delivering critical care. It is manned by at least 4 resident medical officers
round the clock. One Additional Professor looks after the day-to-day clinical
and administrative matters of the PICU and is assisted by one Associate
Professor and one Assistant Professor. Fellows (MUHS) and senior registrars are
also posted in the PICU (when available).
Inclusion Criteria:
All consecutive patients admitted to the PICU with the diagnosis of a
respiratory illness from the age group of 1 month to 12 years of either gender
will be enrolled in the study.
Exclusion Criteria:
The following patients will be
excluded from this study-
1. Patients whose parent/ guardian refuse to give informed
consent.
2. Patients admitted with
non-respiratory illnesses who develop a new respiratory illness after 48 hours
admission to PICU.
3. Patients admitted for non-respiratory
illness/post-trauma cases/ post-operative cases developing respiratory
complications during their PICU stay and patients with tachypnea due to
metabolic acidosis.
Confidentiality:The
participant’s details will not be disclosed at any point of time.
Total number of patients to be studied (sample size
calculation): It has been noticed that the average
number of admissions to the Pediatric ICU is around 400 per year. Of
these, about 20% patients are expected to have primary respiratory
illnesses.24
So,
taking e as 0.05; p = 0.2 , N = 400 & z = 1.96, the sample size is
calculated to be 152.
Z
= 1.96; p = Prevalence of respiratory illnesses in PICU setting = 20% = 0.2; N
= Number of PICU admissions in 12 months = 400; e = Margin of error = 0.05. Sample
size calculation: (1.96*1.96)
* 0.2 (1-0.2) -------------------------------------- 0.05
* 0.05 ————————————————- 1
+ (1.96*1.96) * 0.2 (1-0.2) -------------------------------------- 0.05
* 0.05 * 500
=
152
Study Procedure & Data Recording:
The patient’s daily medical records will be
scrutinized from admission until discharge from PICU or until death of the
patient or transfer to the pediatric ward, whichever is earlier. Readmission of
the same patient to PICU will be counted as a separate case enrolled. This
study will not entail performing any new/ additional investigation or new/
additional treatment or any new/ additional financial burden to the hospital or
financial burden to the parent/ guardian.
Following data/ information will be recorded in a
pre-designed case record form- CRF (from the patient’s hospital case sheets/
indoor medical papers)-
· Demographic
details:
age (in months), sex, weight, socio-economic status, duration of PICU stay
(less than/ equal to 7 days & more than 7 days) and hospital stay (less
than/ equal to 14 days & more than 14 days).
· Clinical
Details: Indication of
PICU admission, Final complete diagnosis (with etiology of the respiratory
illness), Ventilation related data with duration (invasive/ non-invasive/
both), co-morbidities (severe malnutrition, incomplete immunization for the
given age, cardiac illness, respiratory malformations, gastroesophageal reflux-
GER, other organ failure, etc) & complications (Recorded in
Yes/ No format for the following parameters- pleural effusion, empyema, shock,
sepsis, ventilator associated pneumonia- VAP, nosocomial blood stream
infection, and thrombocytopenia).
·
Outcome: Final outcome of the
patient (survival/ death/ discharge taken against medical advice i.e. DAMA with
survival at discharge), length of PICU stay and length of hospital stay.
· Predictors of
mortality: The factors
which will be analyzed for their effect on mortality will include-- age, sex,
malnutrition, socio-economic status- Kuppuswanmy scale, severity of illness
(PIM 2 score), etiology of respiratory illness, need for ventilation (invasive
mechanical ventilation/ non-invasive mechanical ventilation/ both types), total
duration of ventilation in hours, presence of co-morbidities, occurrence of
complications, duration of PICU stay (less than/ equal to 7 days and more
than 7 days)& duration
of hospital stay (less than/ equal to 14 days & more than 14 days).
·
Predictors of Length of Stay (LOS) i.e. PICU stay (less than/ equal to 7 days and more than 7 days)& duration
of hospital stay (less than/ equal
to 14 days & more than 14 days): The factors which will be analyzed for
their effect on LOS will include-- age, sex, malnutrition, socio-economic
status- Kuppuswanmy scale, severity of illness (PIM 2 score), etiology of
respiratory illness, need for ventilation (invasive mechanical ventilation/
non-invasive mechanical ventilation/ both types), total duration of ventilation
in hours, presence of co-morbidities, and occurrence of complications. Plan for Statistical Analysis:
The following statistical tests will
be applied for the various variables and their analysis--
1. The etiology of the respiratory
illness, indication for PICU admission, need for ventilation, type of
ventilation (invasive/ non-invasive), co-mobidities, complications & final
outcome will be listed as percentage of total patients enrolled.
2. Age, weight, duration of PICU stay & duration of
hospital stay will be expressed as mean, standard deviation, median and mode.
3. Predictors of mortality will be analyzed by chi-square
test (p<0.05 will be considered as statistically significant). Regression
analysis will be done for the factors which are found to be significant by
univariate analysis.
Expected Outcomes:
This study will help --
1.
To understand the etiology &
different types of respiratory illnesses requiring PICU admission and their
outcome.
2.
To rationalize the
resources and in framing admission and discharge policy for the patients in
PICU.
References :
1. Dahan M, Gelb A. The identity
target in the post-2015 development agenda. Center for Global Development 2015.
Available from: http://www.cgdev.org/sites/default/files/CGD-Essay-Dahan-Gelb-Role-Identification-Post-2015-ID4D_0.pdf [Last accessed on August 04,
2023.
2. Hasan MM, Saha KK, Yunus RM,
Alam K. Prevalence of acute respiratory infections among children in India:
Regional inequalities and risk factors. Maternal and Child Health Journal
2022;26:1594-1602.
3. Murarkar S, Gothankar J, Doke P, Dhumale G, Pore PD,
Lalwani S et al. Prevalence of the acute respiratory infections and associated factors in the rural areas and urban slum areas of Western Maharashtra,
India: A Community-Based Cross-Sectional Study. Front. Public Health
2021;9:723807.
4. NFHS-5 Factsheet2019-2020. Available from: http://rchiips.org/nfhs/NFHS-5_FCTS/FactSheet_MH.pdf[Last accessed on August 04 2023].
5. Islam F, Sarma R, Debroy A, Kar S, Pal R. Profiling acute respiratory tract infections in
children from Assam, India. J Glob Infect Dis2013;5:8-14.
6.Walke SP, Das R,
Acharya AS, Pemde HK. Incidence, pattern and severity of acute respiratory infections among infants and toddlers of a peri-urban area of Delhi: A 12-month prospective study. Int Sch Res Notices2014;
2014:165152.
7.Dorofaeff T, Mohseni-Bod H, Cox PN. Infections in the PICU. In:
Elzouki AY, Harfi HA, Nazer HM, Stapleton B, Oh W, Whitley RJ(eds). Textbook of
Clinical Paediatrics. Springer-Verlag Berlin Heidelberg: Springer Science &
Business Media, Heidelberg. 2nd edition; 2012:2537-2563.
8. Pneumonia
in children. Geneva: World Health Organisation 2022. Available from http://www.who.int/news-room/fact-sheets/detail/pneumonia [Last accessed on August 04 2023].
9. Chandy S, Manoharan A,
Hameed A, Jones LK, Nachiyar GS, Ramya
MS et al. A study on pediatric respiratory tract infections in hospitalised
children from Chennai. Clinical Epidemiology and Global Health 2022;15:101067
10.Suhasini M, Sardarsulthana
SA, Manjuleswari N,Radhika. Study of pattern of respiratory illnesses admitted
to PICU in children 1 month- 5 years: Indian Journal of Applied Research
2015;5:601-605.
11. Das S, Ray SK, Mukherjee
M, Maitra A, Chatterjee K, Sen S. Epidemiology of admissions with respiratory
illnesses: a single tertiary centre experience. Int J Contemp Pediatr
2017;4:378-382.
12. Revised WHO classification and
treatment of childhood pneumonia at health facilities: Evidence
Summaries.Geneva: World Health Organisation 2014.
Available from http://apps.who.int/iris/bitstream/handle/10665/137319/9789241507813_eng.pdf [Last
accessed on August 04 2023].
13. Bronchiolitis in children:
diagnosis and management.National
Institute for Health and Care Excellence 2015.
Available from www.nice.org.uk/guidance/ng9.
[Last
accessed on August 04 2023 ].
14. Al-Eyadhy AA,
Temsah MH, Alhaboob AA, Aldubayan AK, Alangari MI, Alshaya AM . Asthma changes at a
paediatric intensive care unit after 10 years: Observational study. Ann Thorac
Med 2015;10:243-248.
15.Bhandar R, Patil S,
Kumar S. A study of clinical profile and outcome of children admitted with
respiratory distress in a tertiary care centre. Medpulse International Journal
of Pediatrics 2020;16:68-74.
16. Divecha C, Tullu MS, Chaudhary S. Burden of
respiratory illnesses in pediatric intensive care unit and predictors of
mortality: Experience from a low resource country. Pediatric Pulmonology
2019;54:1234-1241.
17.Maheshwari K, Sharma N.
Clinical profile and outcome of patients admitted to pediatric intensive care
unit in a tertiary care teaching hospital of Puducherry, India. Int J Contemp
Pediatr 2020;7:1280-1283.
18.Moyen E, Kambourou J, Okoko AR, Nguelongo LB,
Bomelefa-Bomel V, Nkounkou KG, et al. Child acute lower respiratory tract
infection in Pediatric Intensive Care unit
at University Hospital of Brazzaville (Congo). Open Journal of
Pediatrics 2018;8:32-41.
19. Hutton HK, Zar HJ, Argent AC. Features and outcome
of children with severe lower respiratory tract infection admitted to a
Pediatric Intensive Care Unit in South Africa. J Trop Pediatr 2019;65:46-54.
20. Singh J, Bhardwar V, Sobti P, Pooni PA. Clinical
profile and outcome of acute respiratory failure in children: A prospective
study in a tertiary care hospital. International Journal of Clinical Pediatrics 2014;3:46-50.
21. Duyu M, Karakaya Z. Viral etiology and outcome of
severe lower respiratory tract infections among critically ill children
admitted to the PICU. Med Intensiva (Engl Ed) 2021;45:447-458.
22.
Ghimire P, Gachhadar R, Piya N, Shreshtha K. Prevalence and factors associated
with acute respiratory infection among under-five children in selected tertiary
hospitals of Kathmandu Valley. PLoS ONE 2022;17:e0265933.
23. Kumar AMK, Badakali AV, Mirji G, Vanaki RN, Pol R.
Clinical profile and outcome of acute lower respiratory tract infection in
children aged between 2 months to 5 years. Int J Contemp Pediatr
2017;4:105-109.
|