TITLE: An audit of intraoperative fluid therapy practices in children undergoing major paediatric abdominal oncosurgeries at a tertiary care cancer centre.

INTRODUCTION & BACKGROUND: -

Intra-operative fluid management is crucial for paediatric patients undergoing major abdominal surgeries to maintain hydration, electrolyte balance, and support the body’s physiological needs during the perioperative period. Traditionally, we were using pediatric deficit and maintenance fluid calculations based on the Holliday and Segar formula. (1) This is based on studies conducted on healthy children more than 70 years ago. Over the years, there has been a liberalisation in the preoperative fasting guidelines permitting the intake of clear fluids until 2 hours prior to the scheduled surgery. (2) These formulae that were designed a few decades ago may therefore not hold true as the children may not present to the operating room with a fluid deficit like in the past.

Recently, there has been a lot of debate about optimal fluid therapy, with concerns regarding the development of over hydration, bowel edema and paralytic ileus, hyponatremia etc with the liberal fluid strategy (3,4). The use of restrictive strategy for intravenous fluid management was shown to be associated with hypo-perfusion and Acute Kidney Injury (AKI) in the peri-operative period (5). This led to the evolution of Goal Directed fluid therapy which has shown improved peri-operative outcomes (6,7). In goal-directed fluid therapy, one or more of the static and/or dynamic parameters are used to guide fluid administration, with a rationale to optimize tissue micro-perfusion.

There is always a dilemma among the anaesthesiologists to choose the appropriate type, quantity, timing and strategy of fluid therapy in the peri-operative period while managing major paediatric gastro-intestinal (GI) surgeries. Factors like intravascular fluid deficits due to preoperative fasting, intra-operative insensible losses would further add to the challenges of optimising fluid therapy in major GI surgeries. Along with the strategy, even the choice of fluid is a topic of debate in the peri-operative setting. Synthetic colloids are also associated with decrease in renal function and coagulation. Use of Balanced crystalloids in resuscitation has shown improved benefits in critical care settings (6). The same knowledge has been extrapolated to the peri-operative settings, but the results were inconsistent. So, with all these strategies and practices widely discussed, lack of consensus has led to a wide variation among the anaesthesiologists in managing peri-operative fluid therapy in major paediatric GI surgeries. We therefore plan to audit the fluid therapy practice patterns in the intra operative period of children undergoing major pediatric abdominal surgeries in our tertiary care cancer centre.

Aim of the study:

To audit the intraoperative intravenous fluid and blood product strategy in children undergoing major paediatric abdominal oncosurgeries.     

Methodology:

Study design-Single arm prospective observational study

Site

Tata memorial Hospital, Parel, Mumbai

The study will start after obtaining approval from Institutional Ethics Committee and CTRI registration. On the day prior to the scheduled surgery, the parents of children will be explained about the study by a member of the study team and given an informed consent form in the language understood by them (English/Hindi/ Marathi). They will be given enough time to go through the consent document and all their queries will be answered. Only those children whose parents give consent for study participation will be recruited for the study. In children between 7-12 years of age verbal assent in addition to the parental consent will be taken and documented in the source documentation notes.

Inclusion Criteria:

1. Children (12 years or younger) posted for Elective abdominal surgeries. (Nephrectomy, neuroblastoma, Hepatoblastoma, germ cell tumours, rhabdomyosarcoma)
2. ASA 1-2 patients

Exclusion Criteria:

1. Children who require emergency surgeries and re-explorations.
2. Patients who are critically ill / admitted in ICU.
3. Children with congenital defects, ASA 3 and 4 children.
4. Children with complex nutrition requirement example- gastrostomy tube feeds, children on TPN etc.

OBJECTIVES-

Primary Objective:

1. To study the amount (quantity in ml/kg) of crystalloids, colloids and blood products administered during intraoperative period in major elective Pediatric abdominal oncosurgeries and the goal directed therapy endpoints used to titrate the fluid therapy i.e. PPV, MAP, Urine output, Arterial lactate etc.

Secondary Objectives:

1. To study the type of fluids and blood products given intraoperatively.
2. To study the incidence and need of supplementing dextrose intraoperatively.
3. Post-operative resumption of oral intake.
4. The incidence of postoperative complications (if any) prolonging length of ICU or hospital stay.
5. Length of ICU stay.
6. Length of hospital stay.

Data Collection:

This will be a single arm prospective observational study on fluid therapy practice. This is an audit of usual practice, with no study-specific interventions. Data will be collected over a period of two years or 100 patients whichever is earlier.

Sample Size:

We plan to begin recruitment after IEC approval and CTRI registration. The study is planned as a dissertation project for MD Anaesthesiology and whatever data will be collected will be submitted as a thesis project in Jan 2025. The study will however continue till 2 years or recruitment of 100 children whichever is earlier.

Statistical Analysis Plan:

Descriptive statistics will be used to summarize the data. Categorical data on clinical,

demographic and intra-operative factors will be presented using counts and percentages.

Normally distributed continuous data on crystalloids, colloids and blood products

administered during intraoperative period will be summarized using mean (standard

deviation). Non-normally distributed continuous data will be summarized using median.

(inter-quartile range). Normality of the continuous data will be assessed using Kolmogorov-

Smirnov’s test for normality. Count and percentages of the type of fluids and blood products will be reported. The incidence of need of supplementing dextrose intraoperatively will be presented in counts and percentages. Post-operative resumption of oral intake. The incidence of postoperative complications will be presented in counts and percentages. Chi-square test will be used to compare the distribution of intra-operative categorical data with demographic and clinical factors. The length of ICU or hospital stay will be compared between the complications using unpaired t-test or Mann-Whitney U test. A p value less than 0.05 will be considered as statistically significant. All statistical analysis will be performed using Licensed IBM SPSS Software Version 29.

References:

1. HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. PMID: 13431307
2. Frykholm, Peter; Disma, Nicola; Andersson, Hanna; Beck, Christiane; Bouvet, Lionel; Cercueil, Eloise; Elliott, Elizabeth; Hofmann, Jan; Isserman, Rebecca; Klaucane, Anna; Kuhn, Fabian; de Queiroz Siqueira, Mathilde; Rosen, David; Rudolph, Diana; Schmidt, Alexander R.; Schmitz, Achim; Stocki, Daniel; Sümpelmann, Robert; Stricker, Paul A.; Thomas, Mark; Veyckemans, Francis; Afshari, Arash. Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care. European Journal of Anaesthesiology 39(1):p 4-25, January 2022. | DOI: 10.1097/EJA.0000000000001599

3. Fluid therapy in the perioperative setting—a clinical review - PMC [Internet]. [cited 2023

           Jan 11]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4833950/

4. Arieff A. Postoperative hyponatraemic encephalopathy following elective surgery in children. Pediatr Anesth. 1998;8:1–4. 

             Available from: https://pubmed.ncbi.nlm.nih.gov/9483590/

5. Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, et al. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263–74.
6. American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on perioperative fluid management within an enhanced recovery pathway for colorectal surgery - PMC [Internet]. [cited 2023 Jan 11].

Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027098/

7. Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392–402.
8. Dong WH, Yan WQ, Song X, Zhou WQ, Chen Z. Fluid resuscitation with balanced crystalloids versus normal saline in critically ill patients: a systematic review and meta-analysis. Scand J Trauma Resusc Emerg Med. 2022 Apr 18;30:28.