跳至主要内容
临床试验/CTRI/2025/07/090293
CTRI/2025/07/090293尚未招募不适用

Incidence and risk factors of perioperative respiratory adverse events in paediatric population of 1 month to 12 years age group undergoing elective surgeries in a tertiary care hospital an observational study.

Fluid grant christian medical college vellore1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
255
试验地点
1
主要终点
To estimate the incidence of perioperative respiratory adverse events in paediatric population of 1month to 12 years age group, undergoing elective general surgeries till their discharge from the hospital.

研究概览

简要总结

PRAEs are common and serious complications in paediatric anaesthesia, significantly increasing hospital stays, healthcare costs, and risks of morbidity and mortality. These events include bronchospasm, laryngospasm, apnea, airway obstruction, desaturation, prolonged oxygen requirements,pneumonitis pulmonary edema and prolonged mechanical ventilation requiring ICU admission.

The proposed research aims to study the incidence and risk factors of PRAEs in our paediatric population of infants to 12 years age group undergoing elective surgeries at our paediatric surgery operation theatres. Young children have high oxygen demands and low oxygen reserves, making them more susceptible to hypoxemia. As per the literature search, the risk factors include younger age, higher ASA physical status, and presence of conditions like chronic lung disease or neuromuscular disorders, airway surgeries, prolonged anesthesia, high FiO2, and intraoperative hemodynamic instability. Our study focuses on seeing the incidence and other associated risk factors amongst the surgeries done in this cohort of paediatric surgery patients in our Indian population.

Additionally, we will be calculating the risk prediction score using SPORC C, which is a recently developed & validated scoring system. This 11 predictors scoring system may help us in classifying children into high & low risk groups. Prediction of PRAEs in our study will be very helpful in anticipating perioperative complications and thereby help in preparing adequately to prevent and treat adverse events successfully, ensuring safe patient care.

Analyzing the findings may help us develop our preanaesthetic assessment of patients and highlight the gaps thereby improving targeted training program. It can help us incorporate the scoring system in our assessment protocol in future that may be beneficial in formulating a treatment plan for patients in high-risk group.

We hope that our results will help with preoperative optimization, careful airway management, and individualized ventilation strategies to mitigate PRAEs, improving outcomes and cost effectiveness associated with paediatric anaesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children of 1month-12 years age group posted for elective general surgery.

排除标准

  • Parents refusal age less than 1 month or more than 12years emergency surgeries patients with tracheostomy in situ Patients on mechanical ventilation airway related ent surgery asa status more than 3.

结局指标

主要结局

To estimate the incidence of perioperative respiratory adverse events in paediatric population of 1month to 12 years age group, undergoing elective general surgeries till their discharge from the hospital.

时间窗: From induction to discharge

次要结局

  • 1. Study the risk factors associated with developing PRAEs in paediatric population during intraoperative postoperative period(From induction to discharge)
  • To assess Score for Prediction of Postoperative Respiratory Complications in Infants and Children SPORC C scoring as a screening tool for risk prediction of perioperative respiratory adverse events in this paediatric population.(From induction to discharge)

研究者

发起方
Fluid grant christian medical college vellore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vejans vishal antony v

Christian medical college

研究点 (1)

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