RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
PREDICTING SURGICAL OUTCOME BY COMPARING SURGICAL APGAR SCORE WITH APACHE II SCORE.
Dr. SACHIN
Post Graduate Student
M.S. GENERAL SURGERY
UNDER GUIDANCE OF
Dr. NISHIKANT GUJAR
M.S.(GENERAL SURGERY)
PROFESSOR
DEPARTMENT OF GENERAL SURGERY
AL – AMEEN MEDICAL COLLEGE, BIJAPUR
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGLORE, KARNATAKA.
1 / Name of the CandidateAnd
Address
(In block letters) / Dr. SACHIN
DEPARTMENT OF GENERAL SURGERY,
AL-AMEEN MEDICAL COLLEGE
BIJAPUR, KARNATAKA.586108.
2 / Name of the Institution / AL-AMEEN MEDICAL COLLEGE
BIJAPUR, KARNATAKA.586108.
3 / Course of study and subject / M.S. GENERAL SURGERY
4 / Date of admission to course / MAY 2013
5 / Title of the Topic / PREDICTING SURGICAL OUTCOME BY COMPARING SURGICAL APGAR SCORE WITH APACHE II SCORE
6 / Brief resume of the intended work :
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the study / ANNEXURE – I
ANNEXURE – II
ANNEXURE – III
7 / Material and Methods
7.1 Study design
7.2 Source of data
7.3 Inclusion criteria
7.4 Exclusion criteria
7.5 Sample size
7.6 Ethical consideration
7.7 Setting
7.8 Method of collection of data / ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
ANNEXURE IV
8 / Does the study require any investigations and interventions to be conducted on patients? If so please describe briefly. / ANNEXURE – V
9 / List of References (about 6 - 8) / ANNEXURE – VI
11 / Signature of the Candidate
12 / Remarks of the Guide / This Study is helpful for predicting outcomes of Surgery.
13 / 13.1 Name & Designation of the Guide (in block letters)
13.2 Signature
13.3 Co-Guide
13.4 Signature
13.5 Head of the Department
13.6 Signature / Dr. NISHIKANT GUJAR
M.S.(GENERAL SURGERY)
PROFESSOR
DEPARTMENT OF GENERAL SURGERY
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
Dr. JELANI.S.AWATI
ASSISTANT PROFESSOR
M.S.(GENERAL SURGERY)
DEPARTMENT OF GENERAL SURGERY
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
Dr. SAJID AHMED MUDHOL
M.S.(GENERAL SURGERY)
PROFESSOR & HEAD OF THE DEPARTMENT OF GENERAL SURGERY
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
14.1 Remarks of the Chairman & Principal
14.2 Signature
ANNEXURE I
NEED FOR STUDY
Hospitals and surgical teams strive to provide a consistently low occurrence of major complications for patients undergoing any surgery. Marked variability in outcomes is inevitable due to the differences in patient’s preoperative risk factors. However, the degree of intra operative patient’s performance in response to surgical stress further contributes to variation in patient’s outcome. Over many years surgical teams have relied on subjective assessment of the patient and feedback within 30 days. The APACHE score and the Physiologic and Operative Severity Score for predicting Mortality and Morbidity (POSSUM) have been proposed as clinical predictors of outcome(1,2). Several studies utilizing the surgical APGAR scoring system have shown that, it gives a satisfactory result in predicting the morbidity and mortality like APACHE and POSSUM in any general or vascular surgery4. As it involves fewer parameters, capable of being accomplished with ease, its utility is being studied here.
There remains no established scoring system for the assessment of risk in surgical patients .however ,in most settings ,the APACHE II score most widely used score to assess hospital mortality. This APACHE II score is based on twelve routine physiological measurements (temperature, heart rate, respiratory rate, mean blood pressure, pH, PaO2,serum sodium levels, serum potassium levels, serum creatinine, haematocrit ,leucocytes count, and Glasgow coma scale),age and the patient’s previous health status. An increasing score ( range :0-71)is predictive of an increased risk of hospital death. Various studies have been carried out to determine the efficacy of APACHE II score in predicting outcomes in surgical patients.
In this study, we aim to evaluate both, surgical Apgar score and APACHE II score as predictors of major post –operative complications and death.
ANNEXURE II
REVIEW OF LITERATURE
In the past surgeons relied principally on “gut-feeling” and pre-op clinical assessment of the patient’s condition to judge the prognosis and guide clinical care. With the evolution of monitoring techniques and well equipped laboratories, newer general and specialized/surgical scoring systems emerged as follows.
General: SAPS II, APACHE II, MODS (Multiple Organ Dysfunction Score)
TRIOS (Three days Recalibrated ICU Outcome Score), etc.
Specialized/ Surgical: POSSUM (Physiologic and Operative Severity Score for the enumeration of Mortality and Morbidity), MPM for cancer patients (surgery, any), Glasgow Coma Score, NSQIP, etc.,
However, they are not easily calculated at the bedside since they need numerous cumbersome clinical and lab data.
It was in 1953, a scoring system for evaluation of the condition of newborn was formulated by Virginia Apgar which was found to be a simple, effective grading system for predicting the performance of a newborn for the first 28 days 1 . A similar effort to arrive at a scoring system has been performed at department of surgery, Brigham and women’s hospital, Massachusetts general hospital and centre for surgery and public health, Boston since 2001. Study conducted on a large cohort of patients undergoing general and vascular surgery showed1,2 in a multivariable logistic regression with 8 of 9 intra operative variables, that lowest heart rate, lowest mean arterial pressure and estimated blood loss were each independent predictors of outcomes 2. These were studied as surgical Apgar score in comparison to NSQIP model (lowest heart rate, estimated blood loss, pulmonary co morbidity and age). Both models had similar ability to discriminate among patients with and without major complications or death.
The Surgical Apgar Score because of its simplicity, availability in real time, immediately usable for clinical decision support and easily and inexpensively collected in any hospital, has made it a powerful tool for broad safety improvement in surgery .
· In 2007 Gawandle et al, developed a post-operative scoring system the Apgar score pattern on the obstetrician’s Apgar score. They developed their scoring system using the medical record of patient who underwent surgery at a large teaching hospital over a period of 22 months. first score was derived using pre-operative, intra operative and outcomes data of cohort of patients who underwent open colectomy, a common procedure known to have a high rate of complications. This score was tested in a different cohort of colectomy patients and then its predictive ability was tested in a larger coherent of patients who underwent any general or vascular surgical procedure. Patient under 16 years of age, trauma surgeries, transplantation surgeries, vascular access surgeries and endoscopic only procedures were excluded. pre-operative co morbidity categories were created according to pre-existing COPD ,ventilator dependence ,pneumonia, earlier MI, congestive heart failure, peripheral vascular disease are coronary re vascularisation. Wound status was dichotomized as clean and clean contaminated in one group, and contaminated and dirty in other.
· 28 intra operative variables were collected for each patient. These included operative duration, initial, final, highest and lowest heart rate and blood pressure during surgery, initial, final and lowest temperature and oxygen saturation, volume of urine output, estimated blood loss(EBL),volume of fluids and blood products administered ,use of pressure support medication and; and anaesthetic type. Primary out comes for the study were death or major complication within 30 days of surgery. major complication was defined as acute renal failure, bleeding requiring>=4 u red cell transfusions within 72 hours of surgery, cardiac arrest, coma for 24 hours or longer, deep venous thrombosis, septic shock MI ,unplanned intubation, ventilator use for 48 hrs. Or longer, pneumonia, pulmonary embolism, stroke, wound disruption,. Deep or organ space surgical site infection, sepsis, and systemic inflammatory response syndrome. Patients having other occurrences such as anastomotic leak and cystic duct leak after cholecystectomy were review for severity. univariety analysis was performed examining the relationship of pre-operative variable to the outcomes of major complications or death. Variables that independently predicted outcomes became candidate for inclusion in the score. It was found that lowest heart rate, log EBL and lowest mean arterial pressure were each independent predictors of outcome. Using both pre-operative and intra operative variables, it was found that the lowest heart rate, log EBL, lowest mean arterial pressure, pulmonary co morbidity and age were in dependent predictors of outcome. These two models had similar ability to discriminate among patients with or without major complications of death. because of its simplicity, be causing having heart rate and not the blood pressure as a component could lead to surgical team managing heart rate without regard to blood pressure ,and because the discriminative ability of the two models was similar the first model was chosen
· The investigators found that as the score increased, out comes improved monotonically .differences in pout come between patients with different scores were also significant statistically. Of their cohort of 767 patients, 11 (1.4%) died and 70(9.1%) developed major complications with on 30 days. The mean surgical score was 7.55(+=1.49sd).the occurrence of major complication or death was significantly associated with the surgical score in univariate logistic regression (p<0.0001).the c statistic was 0.72, indicating good discrimination. Differences in outcomes between patients with different scores were also statistically significant. Among 29 patients (3.8%) with a score <= 4, 17(58.6%) had major complications and are died within 30 days. Among the 220 patients with score of 9 or 10, only 8(3.6%) suffered major complication or death within 30 days. This difference corresponds to relative risk of 16.(95%cl,7.7-34.0,p<0.0001).
· In 2009,regenbogen,Gawandeet.al published their study to confirm the utility of surgical Apgar score. They calculated the surgical Apgar score using electronic intra operative data of 4119 general and vascular surgery patients enrolled in the national surgical quality improvement program at a major medical centre over a period of 2 years the incidence of major complications ( as defined above ) are death within 30 days was measured. Of 1441 patients of score of 9 -10, 72(5%) developed major complications within 30 days, including 2 deaths (o.1%). Among 128 patients with scores of 4 or less,72 developed major complications(56.3%-relative risk 1.3-)of whom 25 dies (19.5%-relative risk 140.7).they concluded that the surgical Apgar score provides a simple and immediate means of measuring an communicating patient outcome in surgery, and a for identifying patients at higher or lower than average likelihood of complications and /or death after surgery
· The acute physiology and chronic health evaluation (APACHE) score is probably the best known and most widely used score. The original APACHE score was first used in 1981 at GEORGE WASHINGTON university medical centre and score for 3 patients factors that influence acute illness outcome (pre-existing disease, patient reserve and severity of acute illness).(6)These include 34 individual variable chronic health evaluation and the 2 combined to produce the severity score
· The APACHE II scoring system was released in 1985 and incorporated a number of changes from original APACHE(11) .these included that a reduction in the number of variables to 12/eliminating infrequently measured variables such as lactate and osmolality .the weighing of other variables were altered; most notably, the weighing’s for J Glasgow coma scale and acute renal failure were increased. In addition, weighing was added end organ dysfunction and points given for emergency are non-operative admissions. Each variable is weighed from 0-4, with higher scores denoting an increasing deviation from normal. The APACHE II is measured during the first 24 hrs. of ICU admission; the maximum score is 71 the score of 25 represents a critical mortality of 50 % and score of over 35 represents a predicted mortality of 80 % the APACHEII severity score has shown a good calibration and discriminatory values across a range of disease processes, and remains the most commonly used international severity scoring system world-wide .APACHE III, released in 1991 was developed with objectives of improved statistical, ability to predict individual patient outcome, and identify their factors in ICU care that influence outcome variations(9). The weighs are far more complex than 2 previous scoring systems, but notably are the addition of HIV and haematological malignancy (as well as disseminated malignancy and liver disease) to the chronic heath points the performance of APACHEIII severity score is slightly better than that of APACHE II, but the former has not achieved the world wide acceptance
· The applicability of the APACHE II score for surgical patient has been controversial. The population used to develop the APACHE II system, the 785 patients who were admitted after coronary by-pass graft procedure were eliminated because “these patients represent a large group whose surgical anaesthesia management resulted in very high scores at admission but comparatively low hospital mortality” (6) in fact, a study in 1990 by Cerra FB et al conclude that APACHE II score did not predict multiple organ failure syndrome and mortality in post operative surgical patients. over a 1 year period,92 patients qualified for the study , 24 of whom survived,69 of whom suffered multiple organ failure syndrome, and 68 whom died. The APACHE II score did not predict the development of multiple organ failure syndrome or mortality with clinical utility and significantly under estimated the potential for the development of multiple organ failure syndrome. however ,Ribeior and Kowalski assessed the value of the APACHE II ,the POSSUM(physiological and operative severity score for the enumeration of mortality and morbidity), and the ASA classification scores in predicting incidence of major complications within 30 days of operation in 530 patients of oro pharyngeal malignancies who underwent surgery.(7) The APACHE II score was calculated with in the first 24 hours of post-operative even in patients who were not referred to the ICU as was the POSSUM score, while the ASA score was calculated pre operatively . Their results showed median APACHE II score of 7 for patients with an uncomplicated course and 8 for those with a complicated post-operative course. The post-operative mortality was found to be significantly higher in patients with an APACHE II score of 10 or more. There was also a statistically significant relationship between the risk of complications and predictive value of each score it was found that the APACHE II and the POSSUM score were equally predictive of post-operative complications and both had better prognostic capacity than the ASA score