Determining the association between pre-operative frailty and nutritional status with the occurrence of emergence delirium and cognitive dysfunction in pediatric patients under general anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.) Nutritional Status
研究概览
简要总结
This investigation is to examine the complex interplay of malnutrition, frailty, and their impact on paediatric health outcomes [1]. Recognizing the severity of malnutrition, prestigious organizations such as the European Society for Clinical Nutrition and Metabolism at Risk (ESPEN) and the European Society for Gastroenterology, Hepatology, and Nutrition (ESPGHAN) recommend for screening at admission [2-4]. This proactive method aims to identify nutritionally at-risk children, enabling for the development of personalized nutritional support treatment plans. The study focuses to the complex interaction between malnutrition and sarcopenia, as well as body habitus abnormalities such sarcopenic obesity (SO) in children. Studies across diverse clinical populations in adults have shown the increased risks associated with SO, emphasizing the limitations of using BMI as a sole nutritional indicator. Frailty assessments and risk stratification, particularly preoperatively, have been recognized as crucial tools for effective patient care planning and critical care resource utilization. study expands to the prevalence of emergence delirium (ED) and postoperative cognitive dysfunction (POCD) in pediatric anesthesia as Current data suggests that the occurrence of ED varies widely, ranging from 20% to 80% of all pediatric anesthesia cases, though the
majority of literature suggests a prevalence closer to 20% and the reported incidence rate of postoperative cognitive dysfunction (POCD) in this population varies from 6.6% to 67%. It is essential, however, to extend our focus to children, whose developing brains may also be susceptible to ED and cognitive alterations.
In conclusion, this comprehensive strategy aims to improve the understanding of the synergistic effects of malnutrition and frailty on development delirium and cognitive impairment in pediatric health care. By shedding light on potential interventions and strategies, the study aims to improve patient outcomes, reduce complications, and increase overall well-being for pediatric patients facing a variety of medical difficulties. The multidimensional approach
deals with essential aspects of pediatric health, emphasizing the value of proactive measurements, detailed evaluations, and individualized interventions for the best patient care.
Ref:
[1] Mehta N.M., Corkins M.R., Lyman B., Malone A., Goday P.S., Carney L.N., MonczkaJ.L., Plogsted S.W., Schwenk W.F. Defining pediatric malnutrition: A paradigm shift toward etiology-related definitions. JPEN J. Parenter. Enteral Nutr. 2013;37:460–481. doi: 10.1177/014860711347997
[2] Agostoni C., Axelson I., Colomb V., Goulet O., Koletzko B., Michaelsen K.F., Puntis J.W., Rigo J., Shamir R., Szajewska H., et al. ESPGHAN Committee on Nutrition; European Society for Paediatric Gastroenterology. The need for nutrition support teams in pediatric units: A commentary by the ESPGHAN committee on nutrition. J. Pediatr. Gastroenterol. Nutr. 2005;41:8–11. doi: 10.1097/01.MPG.0000163735.92142.87.
[3] Teixeira A.F., Viana K.D. Nutritional screening in hospitalized pediatric patients: A systematic review. J. Pediatr. 2016;92:343–352. doi: 10.1016/j.jped.2015.08.011.
[4] Rinninella E., Ruggiero A., Maurizi P., Triarico S., Cintoni M., Mele M.C. Clinical tools to assess nutritional risk and malnutrition in hospitalized children and adolescents. Eur. Rev. Med. Pharmacol. Sci. 2017;21:2690–2701.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 17.00 Year(s)(—)
- 性别
- All
入选标准
- •Pediatric patients under the age of 2 -17 years who will be scheduled for surgery under GA will be included.
- •Parents or legal guardians of pediatric patients who provide written informed consent will be eligible for inclusion.
- •Patients with a baseline Glasgow Coma Scale score of 15/15 and an expected duration of surgery exceeding 60 minutes will be included.
排除标准
- •History suggestive of dementia (either listed in the medical record or reported by the patient) or any neurological disorder 2) History of any cerebral surgeries 3) History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other disorder affecting cognition, mental dysfunction 4) Prescription of central nervous system active medication (eg: antidepressants, antipsychotics, sedatives).
结局指标
主要结局
1.) Nutritional Status
时间窗: 1.) 24 hours preoperative | 2.) Postoperative 30 minutes, 24 hours and 48 hours | 3.) Follow up 1 week, 3 months and 6 months
2.) Sarcopenia
时间窗: 1.) 24 hours preoperative | 2.) Postoperative 30 minutes, 24 hours and 48 hours | 3.) Follow up 1 week, 3 months and 6 months
3.) Frailty Score
时间窗: 1.) 24 hours preoperative | 2.) Postoperative 30 minutes, 24 hours and 48 hours | 3.) Follow up 1 week, 3 months and 6 months
4.) Paediatric anaesthesia emergence delirium
时间窗: 1.) 24 hours preoperative | 2.) Postoperative 30 minutes, 24 hours and 48 hours | 3.) Follow up 1 week, 3 months and 6 months
5.) Post operative cognitive dysfunction.
时间窗: 1.) 24 hours preoperative | 2.) Postoperative 30 minutes, 24 hours and 48 hours | 3.) Follow up 1 week, 3 months and 6 months
次要结局
- 1.) Post operative cognitive dysfunction for follow-up time periods scheduled for 1 week, 3 months, and 6 months. (Through telephonic discussion).(1 week, 3 months, and 6 months.)
研究者
Dr puneet Khanna
All India Institute of Medical Science
