Intra operative monitoring of cerebral oxygen saturation using Near Infra Red Spectroscopy (NIRS) and Assessment of risk factors for Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity during Vitreo retinal surgeries:An observational prospective study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To find out the incidence of low cerebral oxygen saturation (mild-severe) in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgery
研究概览
简要总结
Intra operative monitoring of cerebral oxygen saturation using Near Infra Red Spectroscopy (NIRS) and assessment of risk factors for Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity during Vitreo retinal surgeries:An observational prospective study will be conducting in 50 preterm and very preterm infants upto 6months of age with retinopathy of prematurity who are posted for elective Vitreo retinal surgeries to find out the indicence of Low cerebral oxygen saturation in these infants and to describe the differences in regional cerebral oxygen saturation during different time lines of anesthesia using Near Infra Red Spectroscopy and also to identify factors associated with low cerebral oxygen saturation in these patients. Study will be conducting at Dr.Rajendra Prasad Center for Ophthalmic Sciences,AIIMS New Delhi under Department of Anaesthesilogy Pain medicine and Critical Care,AIIMS New Delhi.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Preterm and very preterm infants with post conceptional age of 31 to 60 weeks or up to 6 months of age with Retinopathy of prematurity posted for elective Vitreo retinal surgery 2.Infants uptown 5kg weight 3.Including single and both eye Video retinal surgeries 4.Duration of surgery more than half an hour 5.Patients with mild congenital heart disease such as mild PS,mild AS,VSD can be included in this study.
排除标准
- •1.Patient parental refusal for consent 2.Associated moderate-severe congenital heart disease involving major cardio vascular shunting 3.Diagnosed with any neurological disease of brain 4.Associated structural malformations of frontal brain or scalp or skull by history or physical examination.
结局指标
主要结局
To find out the incidence of low cerebral oxygen saturation (mild-severe) in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgery
时间窗: 1.Mild-relative decrease in rScO2 of 11-20% from baseline value or absolute rScO2 60-69% for more than 3 minute | 2.Moderate -decrease of 21-30% from baseline value or absolute value 50-55% for more than 3 minutes | 3.Severe-relative decrease in rScO2 greater than 30% below baseline or absolute value less than 50% for more than 3 minutes
次要结局
- To identify factors associated with Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgery(1.Preterm-babies born alive before 37 weeks of gestational age)
- To describe differences in regional cerebral oxygen saturation (rScO2) during different timelines of anaesthesia such as induction,during surgery and extubation(1.Baseline-time between placement of NIRS probe on patients forehead before induction of anesthesia and administration of anaesthetic drugs or supplemental oxygen to induce anesthesia)