BRIEF RESUME OF INTENDED WORK
ANNEXURE I
6.1 NEED FOR THE STUDY
Nosocomial infections affect about 30% of patients in intensive-care units and are associated with substantial morbidity and mortality. Hospital-acquired infections add to functional disability and emotional stress of the patient and may,in some cases, lead to disabling conditions that reduce the quality of life. The advances to be made in critical care are hampered by the increasing incidence of nosocomial Intensive Care Unit (ICU) infections. These infections are acknowledged to be a major growing clinical problem in hospitals worldwide, and within the ICU in particular. ICU patients become more prone to develop infections as the severity of their illness increases.
Modern intensive care medicine has to deal with more complex critically ill patients with a temporarily compromised immunity and a plethora of aggressive invasive diagnostics and devices that breach their host defences.
The rate of Nosocomial infections in the Intensive Care Unit is rising, mainly because of theincreasing use of invasive procedures which are performed in the Intensive Care Unit . The therapeutic interventions which are associated with infectious complications include indwellingcatheters, sophisticated life support, intravenous fluid therapy, prosthetic devices, immunosuppressive therapy, changes in the population at risk and the use of broad spectrum antibiotics leading to a spectrum of multidrug resistant pathogens, which contributed to the evolution of the problem ofnosocomial infections.
The most common Nosocomial infections that could occur in an ICU are: -
1. Catheter associated Urinary tract infections 2. Line associated Blood stream infections 3. Ventilator associated pneumonia 4. Surgical site infections
Keeping this in view, the present study is conducted to estimate the incidence of nosocomial infections in the ICU in Dr B R Ambedkar Medical College Hospital, the risk factors associated with it and to detect the pathogen causing the infection and their antibiotic susceptibility patterns.
ANNEXURE II
REVIEW OF LITERATURE
Nosocomial infections (NI) are responsible for morbidity and mortality in hospitalized patients. They also increase the cost of treatment and prolong hospitalization. The Centre for Disease Control and Prevention (CDC) defines the intensive care unit associated infections as those that occur after 48 hours of ICU admissions or within 48 hours after the transfer of the patients from the ICU.1 Nosocomial infections affect about 30% of patients in intensivecare units and are associated with substantial morbidity and mortality. Several risk factors have been identified, including the use of catheters and other invasive equipment, and certain groups of patient -eg, those with trauma or burns—are recognised as being more susceptible to nosocomial infection than others. Awareness of these factors and adherence to simple preventive measures, such as adequate hand hygiene, can limit the burden of disease.2
Adherence to aseptic technique, hand hygiene practices, care for invasive lines and ventilator care can do much to reduce the incidence. Several other objectives should be kept in mind-- The removal of invasive devices as quickly as possible,Vigilance of Health Care Workers in observing visitors for signs of infections, education for visitors on the importance of hand hygiene.3 In a study conducted in 2008,major infections found in ICU were due to Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pyogenes. The infection rate was maximum in urinary tract (44.4%) followed by wound infections (29.4%), pneumonia (10.7%) and bronchitis (7.4%).4 In a study conducted in 2010,the overall infection rate for Catheter associated Urinary tract infections(CA-UTI), Line associated Blood stream infections and Ventilator associated pneumonia were found to be 0.6, 0.48, and 21.92 per 1000 device days, respectively. The organisms isolated were Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa. Duration of indwelling devices was found to be the major risk- factor for acquiring Device Associated Infections. 5
In a study conducted in 2010,the rate of nosocomial infections was 27. 4%. The rates of the urinary,respiratory and the intravascular catheter related infections were 55.52%, 35.78% and11.52%, respectively. Klebsiella pneumoniae and Staphylococcus aureus were the most common isolates with maximum susceptibility to Imipenem and Vancomycin respectively.6
In a study conducted in 1999.,Nosocomial infections were analyzed by infection site and pathogen distribution. Urinary tract infections were most frequent (31%), followed by pneumonia (27%) and primary bloodstream infections (19%). Eighty-seven percent of primary bloodstream infections were associated with central lines, 86% of nosocomial pneumonia was associated with mechanical ventilation, and 95% of urinary tract infections were associated with urinary catheters.7
A prevalence survey conducted under the auspices of WHO in 55 hospitals of 14 countries representing four WHO Regions (Europe, Eastern Mediterranean,South-East Asia and Western Pacific) showed an average of 8.7% of hospital patients had nosocomial infections.8 ANNEXURE III
6.3 Objective of the study
1. To plan proper Hospital infection control strategy to prevent Nosocomial infections.
2. To study the incidence of nosocomial infections in the ICU of a tertiary care hospital
3. To study the risk factors associated with Nosocomial infections
4. To study the antibiotic susceptibility pattern of the pathogens causing Nosocomial infections
7.MATERIALS AND METHODS
7.1 SOURCE DATA
Data will be collected from patients admitted to ICU of DR B R Ambedkar Medical College Hospital, and who develop new infection after 48 hours of admission.
This Hospital caters to population hailing from the surrounding areas of Venkateshpura,Shampura,Nagawara,Hegdenagar,Kavalbyrasandra and Sultanpalya.
ANNEXURE V
7.2 METHOD OF COLLECTION OF DATA
Duration of study:
Study will be conducted on samples collected during a period of one and a half years between Nov 2012 to Dec 2013.
Type of study:
This is a prospective study of all patients admitted to ICU developing Nosocomial Infections during the study period.
Place of study:
This study will be conducted at the Department of Microbiology,Dr B.R. Ambedkar Medical College Hospital.
Inclusion Criteria:
Patients admitted to ICU for another illness and who develops one or more of the following new symptoms after 48 hours of admission were included in the study.
1. Unexplained Fever >380C with chills and rigors and leukocytes >10,000/cu.mm 2. Cough with sputum production,new infiltrates on chest x-ray, persistent tracheal or endotracheal tube aspirates or secretions
3. Change in frequency of urine,suprapubic tenderness, dysuria and burning micturition
4.Pain, tenderness or purulent discharge at the site of IV access
Exclusion Criteria:
1. Pregnant women admitted to ICU for any illness.
2. Patients developing one or more of the above symptoms due to the disease which was incubating at the time of admission.
Evaluation and investigations required:
A detailed medical history will be taken with reference to the reason for admission to ICU, need for Devices or surgery. A note on socio-economic status of the patient will also be made.
The following samples are collected for the specific infections
Sl. No Infection Samples to be collected
1 Catheter associated Urinary Tract Infection Urine 2 Line associated Blood Stream Infection Blood 3 Ventilator associated pneumonia Sputum,/tracheal aspirate/BAL 4 Surgical Site infection Pus/exudate
Samples will be collected and sent to the lab under aseptic precautions.
Urine,tracheal aspirate, pus, sputum samples will be processed as follows.
Urine: The preferred collection method is a early morning midstream, clean-catch specimen. Specimens collected from a newly inserted urine catheter are reliable, providing that proper insertion technique had been followed. Demonstration of Leukocytosis and pyuria, i.e., more than 10 pus cells per cubic milliliter of urine was considered to be sufficient for the diagnosis of urinary tract infections (UTI). Urine culture-sensitivity will be done for those with pyuria. Culture will be done on Cysteine Lactose Electrolyte Deficient(CLED) agar, incubated aerobically at 370C for 24 hrs.The culture will be examined for growth after 24-48 hrs. Presence of 105 CFU of a single organism per ml of urine can be considered diagnostic of UTI.
Tracheal aspirate/Sputum /Broncho Alveolar lavage:Sample is collected in sterile bottles and sent to laboratory under aseptic precautions.Gram stain showing one or more typesof bacteria and more than 25 neutrophils per low power field were selected for culture and growth.Culture will be done on Blood and MacConKey’s agar,incubated at 370C for 24 hrs.The culture will be examined for growth after 24-48 hrs.Demonstration of Leukocytosis in Grams staining and positive culture on Blood agar and MacConKeys agar with evidence of Pneumonia on Chest X ray can be considered diagnostic of Ventilator Associated Pneumonia.
Pus and exudate: Pus or exudate from the infected surgical site is taken by a sterile swab and sent to laboratory under aspeptic precautions.Culture will be done on Blood and MacConKey’sagar,incubated at 370C for 24 hrs.The culture will be examined for growth after 24-48 hrs. Blood:Two samples of blood collected simultaneously, one through the central venous catheter and other from peripheral vein, cultured using paired qualitative method by differential time to positivity. This method monitors bacterial growth and compares the time to positivity for both samples.About 2ml to 3ml of blood is drawn into 5ml-10ml of culture media, with the help of a sterile needle and inoculated into Brain-heart infusion broth, incubated and observed after 24hrs,48hrs,72hrs for growth and turbidity.Then it is subcultured on Blood agar and Macconkeys agar and will be incubated aerobically at 370C for 24 hrs. The culture will be examined for growth after 24-48 hrs.Positive culture is indicative of BSI. Negative cultutre will be reported only after confirming no growth for 7 days. Identification of the causative organism will be done by gram staining of the isolated colonies obtained on culture plates and biochemical reactions.
Antimicrobial sensitivity pattern of the pathogen will be done using the Kirby-Bauer disc diffusion Method on Mueller- Hinton agar using Clinical Laboratory Standards Institute(CLSI) guidelines.The results thus obtained are correlated. ANNEXURE VI
7.3 Statistical Analysis using microsoft Excel
The data analysis involves transcription, preliminary data inspection, content analysis and interpretation. Percentages,Chi-square test and other necessary tests are used in this study to analyse epidemiological variables.
ANNEXURE VII
7.4 Does the study require any investigation or interventions to be conducted on patients or other humans or animals?
No, the study doesn’t require any investigation or interventions to be conducted on patients or other humans or animals.
ANNEXURE VIII
7.5 Has ethical clearance been obtained from your institution in case of 7.4?
Yes ANNEXURE IX
8. List of References
1. Akash Deep, R. Ghildiyal, S. Kandian ,N.Shinkre. Clinical and Microbiological Profile of Nosocomial infections in the Pediatricintensive care Unit. Indian Pediatr2004;41:1238- 1246.
2. The Lancet, Volume 361, Issue 9374, Pages 2068 - 2077, 14 June 2003
3. Infection Control in the ICU:The Final Frontier By Kathy Dix june1,2002
4.Patwardhan RB, Dhakephalkar PK, Niphadkar KB, Chopade BA -A study on nosocomial pathogens in ICU with special reference to multiresistantAcinetobacterbaumannii harbouring multiple plasmids. 2008 Aug;128(2):178-87. 5.S Singh, Y Pandya, R Patel, M Paliwal, A Wilson, S TrivediSurveillance of device- associated infections at a teaching hospital in rural Gujarat – India Year : 2010; Volume : 28 ;Issue : 4; Page : 342-347
6.Shalini S, Kranthi K, gopalkrishnaBhat K. The Microbiological Profile of Nosocomial Infections in Intensive care Unit. Journal of clinical and Diagnostic research(Serial online)2010 Oct(Cited :2010 Oct 31)4:3109-3112
7. Richards MJ, Edwards JR, Culver DH, GaynesRP..Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System.1999 May;27(5):887-92.
8.WHO/CDS/CSR/EPH/2002.12 Prevention of hospital-acquired infections,A practical guide,2nd edition