Rajiv Gandhi University of Health Sciences Bangalore s3

Annexure – I RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate DR.YOGENDRA. V and address (in block letters) #4, SRI BALAJI NILAYA, 9th CROSS, 2nd MAIN ROAD, B.K. NAGAR, YESHWANTHPUR, BANGALORE- 560022. KARNATAKA.

2. Name of the institution VYDEHI INSTITURE OF MEDICAL SCIENCES AND RESEARCH HOSPITAL.

3. Course of study and subject M.D. (ANAESTHESIA)

4. Date of admission to course 30th AUGUST, 2013.

5. Title of the Topic :

ESTIMATION OF INTRA-OPERATIVE BLOOD LOSS BY GRAVIMETRIC METHOD vs. HEMOGLOBIN & HEMATOCRIT METHOD, IN JOINT REPLACEMENT SURGERIES UNDER REGIONAL ANAESTHESIA

6. Brief resume of the intended work:

6.1. Need for the study:

Intraoperative blood loss is a complex issue. Estimation of intraoperative blood loss is an integral

part of any surgical procedure. Quantifying blood loss during a surgical procedure, supplemented with

other variables such as blood pressure and tissue perfusion, is essential in the ongoing evaluation of a

patient’s general condition and to assess and modify intraoperative and postoperative management.

Disproportionate blood loss, not showing in the form of hemodynamic variables can have bearing on postoperative recovery demanding blood transfusion. Hence, blood loss estimation becomes an integral part of intraoperative monitoring [1, 5]. Joint replacement surgeries are common in elderly patients with multiple comorbidities, in whom this may be more important. This study aims at optimizing perioperative blood transfusion so that required transfusions are facilitated and unnecessary transfusions are avoided, thus reducing the perioperative morbidity, in joint replacement surgeries.

6.2. Review of literature:

There are prospective randomized controlled studies to address the most appropriate methods for predicting blood loss. A review of all meta-analysis studies on blood loss measurement, reveal the level of evidence is low in regards to most conclusions and statements in the literature. Mathematical models, such as those proposed by Brecher et al [1] have reported that calculations of blood loss were on average 2.1 times greater than the estimated blood loss provided by anesthesia.

Gravimetric methods have been reported in many studies. Lee et al [2] in his study has concluded that estimation of blood loss using a gravimetric method is accurate and applicable in the clinical setting and provides surgeons with a simple and objective tool to evaluate intraoperative blood loss.

Similarly, studies by Thronton et al [3], Baronofsky et al [4] & James H et al [5], also advocated the general adoption of the swab weighing method because of its simplicity and near accurate method. He also concluded that these methods of blood loss estimation do not supersede the traditional methods of the clinical assessment of the surgical patient, but are valuable adjuncts to such assessment. Desalu I

[6] and colleagues reported that visual estimation of blood loss was notoriously unreliable and gravimetric method is real good indicator for intraoperative blood transfusions.

Furthermore, Sehat KR [7] and colleagues compared visual assessment of blood loss with objective methods and found the “hidden” blood losses associated with knee and hip arthroplasties cannot be estimated by visual (subjective) methods.

The measurement of preoperative hemoglobin and hematocrit will provide a baseline for

measuring trends intra-operatively. Blood lost intra-operatively has, in theory, a hematocrit similar to

the pre-operative value. Howe and colleagues [8], in their retrospective study showed that the mean

difference of preoperative hemoglobin vs. postoperative hemoglobin & hematocrit is a good indicator

and further Mark et al [9] in their prospective study, to correlate the raise in hemoglobin and hematocrit

following blood transfusion have stated that 1g loss of hemoglobin correlates with 3% decrease in

hematocrit which is equivalent to 500ml blood loss.

6.3. Objectives of the study:

To compare gravimetric method vs. hemoglobin & hematocrit method as an indicator of

intraoperative blood loss, in joint replacement surgeries under regional anaesthesia.

7. Materials and Methods:

7.1. Source of data:

This study will be done on 50 patients coming to our Operation Theatre for joint

replacement surgeries at Vydehi Institute of Medical Sciences & Research Centre, Bangalore.

7.2. Method of collection of data (including sampling procedure, if any)

1) Definition of a study subject:

All the patients admitted to our Hospital & posted for joint replacement surgeries

under regional anesthesia with ASA grade 1-3 will be included for the study,

extending from January, 2014 to January, 2015.

2) Inclusion criteria:  All joint replacement surgeries of ASA grade 1 to 3.

 Informed consent obtained.

3) Exclusion criteria:

 Revision Surgeries

 Patients with established blood dyscrasias

 Patients on anticoagulant therapy

4) Methodology:

Before surgery, the surgical mops of standard size will be pre-weighed and following

surgery the blood soaked surgical mops will be post-weighed. Intraoperative blood

loss will be determined as the weight difference between the sterile mops pre and

postoperatively. 1g of difference in weight of surgical mop will be equal to 1ml of

blood [3]. This will be compared with preoperative and immediate postoperative

values of hemoglobin & hematocrit. 3% decrease in hematocrit or 1g decrease in

hemoglobin is equivalent to 1 unit (i.e. 500ml) loss of blood [9]. The aim would be to

establish the better method of predictor of blood loss.

5) Statistics:

Comparison of gravimetric vs hematocrit method will be done using Chi-square test.

7.3. Does the study require any investiga tion or interventions to be conducted on patients

or other humans or animals? If so, please describe briefly.

Pre-operative and postoperative haemoglobin and haematocrit values

7.4. Has ethical clearance been obtained from your institution in case of 7.3?

Yes- in accordance with the ethical committee.

8. List of references: 1. Brecher M, Monk T, Goodnough L. “A Standardized method for calculating blood loss”.

Transfusion. 37, Oct 1997; 1070-74

2. Lee MH, Ingvertsen BT, Kirpensteijn J, Jensen AL, Kristensen AT. “Quantification of surgical

blood loss”. Vet Surg. 2006 Jun; 35(4):388-93.

3. J. A. Thornton. “Estimation of blood loss during surgery”. Ann R Coll Surg Engl. 1963

September; 33(3): 164–174.

4. Baronofsky I. D., Trolar A. E., and Wangensteen 0. H. (1946) Surgery, 20, 761.

5. James H Macleod. “General Practice: Estimation of Blood Loss”. Canad. Med. Ass. J. July

16,1966; vol. 95:114-7

6. Desalu I, Kushimo OT, Bode CO, Adeyemo WL. “Appropriateness of intra-operative blood

transfusion in children at the Lagos University Teaching Hospital--an initial survey”. Nig Q J

Hosp Med. 2009 Jul-Sep; 19(3):131-4.

7. K. R. Sehat, R. L. Evans, J. H. Newman et al. “Hidden blood loss following hip and knee

Arthroplasty”. Journal of Bone Joint Surgies [Br] 2004; 86-B: 561-5.

8. Howe C, Paschall C, Panwalkar A, Beal J et al. “A model for clinical estimation of

perioperative hemorrhage”. Clin Appl Thromb Hemost. 2003 Apr; 9(2):131-5.

9. Mark E. Elzik, Douglas R. Dirschl, and Laurence E. Dahners. “Correlation of Transfusion

Volume to Change in Hematocrit”. American Journal of Hematology 2006; 81:145–146

9. Signature of Candidate

10. Remarks of the Guide:

Undetectable blood loss in joint replacement surgeries accounts to increased perioperative morbidity. This study aims at estimating total intraoperative blood loss by objective methods.

11. Name & Designation of : (in block letters)

11.1 Guide: DR. SUNITHA. K. S

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of Department DR. SADANAND GOPAL

11.6 Signature

12. 12.1 Remarks of the Chairman/Principal

12.2 Signature