Conservative versus Conventional oxygenation target in children admitted in PICU - A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical outcome for composite of death & days of organ support at 4 weeks
研究概览
简要总结
Soon after admission to Pediatric intensive care unit, Department of Pediatrics, AIIMS, Raipur, the patient will undergo screening for enrolment based on inclusion and exclusion criteria. If the patient does not meet the inclusion criteria, he/she will be excluded. As hypoxia can be life threatening and delay can be detrimental oxygen therapy will be started as soon as possible as per unit protocol and clinician judgement. After stabilisation, and inclusion into the study informed consent will be obtained from the patient’s legal guardian. Once consent is obtained patient will be randomised using computer generated block randomisation with concealed allocation. The primary details and the disease status of the patient will be recorded in both the groups. Participants will be randomly allocated (1:1) to either the conservative (88%–92%) or conventional (94%-99%) oxygen target group by a computer-generated dynamic procedure (minimisation) with a random component. Patient in the intervention group will be monitored and titrated to maintain oxygen saturation 88- 92 % with titration of FIO2 and pressure support. This will be continued until all respiratory support (delivered invasively or non-invasively) has been discontinued during this PICU admission.
Prior to randomisation, all care will be determined by the clinical team primarily responsible for the child’s treatment and care. Once randomised, all care other than that intended to achieve trial target SpO2 will be determined by the clinical team. Patient will be monitored hourly SpO2 for duration of need of oxygen support. PaO2 will be monitored at baseline and as per patient clinical need and on clinician judgement. At the baseline and at the end of 7 days or end of oxygen therapy whichever is earlier, we will send serum quantitative MDA levels to see oxidative stress in patients. Clinical parameters, need of ventilation support, duration of ventilation, organ dysfunction, mortality will be recorded till day 30 of inclusion and/ or till PEM/ PICU/ HDU stay. Primary and secondary outcome will be recorded in prescribed format for 30 day after enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Age >1 month to <15 year, who need oxygen therapy for hypoxia or distress in form of invasive or non invasive support.
排除标准
- •Death is imminent Brain pathology/ injury as primary reason for admission (traumatic brain injury, post cardiac arrest, stroke, convulsive status epilepticus without aspiration) Known pulmonary hypertension Known sickle cell disease/ Anaemia Hb < 7 g/dl Known uncorrected congenital heart disease End of life care plan with limit to resuscitation Long term invasive ventilation prior to admission Recruited in previous admission.
结局指标
主要结局
Clinical outcome for composite of death & days of organ support at 4 weeks
时间窗: Clinical outcome for composite of death & days of organ support at 4 weeks
次要结局
- Mortality at PICU discharge(Days of ventilation needed)