Hypertonic saline vs salbutamol in acute bronchiolitis
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THESIS PROPOSAL-SCIENTIFIC COMMITTEE Guide : Dr. G.Senthil Kumaran Dr.M.Narendranath I yr Post graduate Pediatrics
TITLE Comparative study of 3% Hypertonic Saline vs Salbutamol in the treatment of Acute bronchiolitis in Children admitted in tertiary care hospital
OBJECTIVES PRIMARY Comparison of improvement in BSS ( Bronchiolitis severity score) in between two treatment groups from admission to till 24 hrs after admission Length of hospitalization SECONDARY OBJECTIVES: To measure the need for non invasive ventilation To evaluate the safety of hypertonic saline and salbutamol Need for hospital readmission
BACKGROUND AND JUSTIFICATION Acute Bronchiolitis is a common Lower respiratory tract infection Primarily affect infants and young children Definition of Bronchiolitis includes - the First episode of Wheezing along with symptoms of upper respiratory tract infection such as cough, rhinorrhea and low grade fever. It is characterised by inflammation and narrowing of the small airways in the lungs leading to symptoms such as cough , wheezing, difficulty breathing . While most cases of Bronchiolitis are mild and self limiting, severe cases can result in respiratory failure and require Hospitalisation
BACKGROUND AND JUSTIFICATION The mainstay of treatment includes hydration and oxygen therapy as per NICE guidelines, Neb hypertonic saline has a weak recommendation from AAP. However bronchodilators like salbutamol have been used widely to relieve the symptoms and improve outcomes in patients with acute Bronchiolitis A systematic comparison of their impact on various outcomes such as symptoms improvement ,reduction in hospital admission, length of Hospital stay and need for additional intervention will provide valuable insights into their relative merits and limitations
EPIDEMIOLOGY The peak incidence between 2 to 6 months in India outbreaks occur between September to march Age wise incidence of acute Bronchiolitis in less than 1 year of age is 76% and in less than 2 years of age is 94% . Preterm infants had similar rates compared to term infants of 5.2 per 1000 Infants born at < 30 weeks of gestation had the highest hospitalisation rate at 18.7 children per 1000
ETIOLOGY Bronchiolitis is usually a consequence of viral respiratory tract infection RSV is the most common underlying viral agent and has been isolated from 50 to 75% of children younger than two years of age Other common respiratory viral pathogens such as influenza , para influenza and adenovirus Recent investigations demonstrate that some children with bronchiolitis may also be infected with rhino virus .
PATHOPHYSIOLOGY
RISK FACTORS Age less than 3 months Low birth weight Gestational age Lower socioeconomic group Parental smoking Crowded living conditions Chronic lung disease,airway anomalies Hemodynamically significant congenital heart disease Immunodeficiency diseases
Study design:- Academic trial, open label Sample Size:- 50 children admitted in ward and PICU Time duration :- one year
METHODOLOGY INCLUSION CRITERIA:- All paediatrics patients aged 1 month to 24 months hospitalised with clinical diagnosis of acute bronchiolitis with bronchiolitis severity score more than 4 at the time of admission ( moderate to severe bronchiolitis) EXCLUSION CRITERIA:- Previous episode of wheezing Hemodynamically significant heart disease K/C Immunodeficiency Bronchopulmonary dysplasia Syndromic child Imminent need for mechanical ventilation at the time of admission
Bronchiolitis severity score
METHODOLOGY Those children admitted in ward and PICU of tertiary care hospital will be selected after fulfilment of both inclusion and exclusion criteria After a detailed history and clinical examination the diagnosis of bronchiolitis is confirmed Informed consent is taken from the parents of all children and they are randomly allocated in to either of the two groups by randomization Group 1 receives 3 ml of Nebulized 3% Hypertonic saline and group 2 receives 0.5 ml for infants and 1 ml for children aged 12 to 24 months nebulised salbutamol (250 ug/ml) in 3 ml normal saline. For 5 minutes each at 6 -8 th hrly along with other supportive measures like hydration and oxygen therapy if required and assessed in term of improvement of symptoms
CONTD. All of the children are assessed in the beginning and after each nebulization with special emphasis on heart rate, respiratory rate ,BSS score and oxygen saturation by pulse oximetry Patients are followed up after the completion of 24 hours to assess the status at that time Oxygen will be supplemented if oxygen saturation is below 94% All the children are continuously monitored through out the study duration
CONTD. In the event of persistent hypoxia not responding to oxygen therapy , child will be considered as a candidate for mechanical ventilation. Patients will be considered for discharge if they are not requiring supplemental oxygen to maintain oxygen saturation more than 94% ,are feeding adequately ,absent wheezing and Bronchiolitis severity score <4. Both the groups will receive standard treat as per protocols such as airway support, iv fluids and supplemental oxygen I will record the relevant outcomes such as early control of symptoms ,length of hospital stay, need for mechanical ventilation, need for hospital readmission. All the data will be recorded preformed proforma and analysis will be done using appropriate statistical measures.
Informed consent Randomization 0, 8 th hr,16 th hr & 24 hrs METHODOLOGY Both gps will receive std Rx Early Control Of Symptoms ,Length Of Hospital Stay, Need For Mechanical Ventilation, Need For Hospital Readmission Analyzed
PROFORMA SR No: IP No. Random no. Name Sex: M / F Age: DELIVERY DATA Gestation age: BABY’S INFORMATION AT BIRTH Congenital malformations:[y/n OUTCOMES Symptoms controlled at ………. Hrs/ days of admission Need for mechanical ventilation Time to achieve full feeds Oxygen saturation BSS score at discharge Chest in drawing Respiratory rate Heart rate Side effect profile T achycardia Investigations Cbc Crp Chest xray Final Outcome Discharged Expired referral
PROFORMA Parameters Before nebulization 8 hours after admission 16 hours after admission 24 hours after admission Heart rate Oxygen saturation Respiratory rate Bronchiolitis severity score