Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
研究概览
简要总结
The goal of this RCT is to demonstrate that, in neonatal anesthesia, the use of Lung Ultrasound (LUS) to guide choice of best Positive End-Expiratory Pressure (Peep) - the one that efficiently avoids lung atelectasis - leads to better gas exchange in the lung thus can lead to reduction of FiO2 applied to ventilatory setting in order to achieve same peripheral saturations of oxygen (SpO2).
Specific aims of the study are:
- to determine if LUS-guided PEEP choice in neonatal anesthesia, compared to standard PEEP choice, can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
- to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.
- to compare static respiratory system compliance between groups.
- to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups.
详细描述
The investigators plan to perform a single-center randomised, controlled trial, in compliance with the Helsinki Declaration and local regulatory agreements. Patients of age under two months scheduled for general anesthesia due to elective or urgent surgery will be eligible for enrolment. Eligible cases will be treated by only two experienced anesthesiologists (with more than 10-year experience in pediatric field) who underwent a formal LUS training, in order to reduce operator-dependency of the results. Parental consent to the study will be obtained before entering operatory room.
Both groups will be preliminarily scanned with LUS in the posterior areas before induction of anesthesia, upon entrance into the operatory theatre. Posterior areas of the chest will be defined as the area between the posterior axillary line and the spine, not including the scapular area. This will be further categorized into Upper and Lower as divided by an imaginary line passing through the nipples so that 4 posterior areas are identified: Right Upper Zone, Right Lower Zone, Left Upper Zone, Left Lower zone. For every zone, presence of multiple B lines and subpleural consolidations will be noted. The same ultrasound machine will be used for all cases.
In both groups a standard tidal volume of 6 ml/kg and a standard respiratory rate of 30/min will be applied after anesthesia induction and endotracheal intubation.
Patients will be randomised through the Stata software randomizer just before entering operatory room into one of the 2 following groups:
Intervention group: after induction of anesthesia and intubation, patients will be briefly turned onto their side and LUS will be performed in the posterior areas of the lung; PEEP will be adjusted in increments of 1 cmH20/minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations and/or multiple B lines are not present anymore.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 33 Weeks 至 50 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients born after 33 weeks of gestationand up to the age of 50 post-conceptional weeks undergoing elective or urgent surgery requiring general anesthesia with endotracheal intubation
排除标准
- •born at less than 33 weeks of gestation
- •patients with signs or symptoms of cardiac or lung abnormalities or diseases
- •patients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditions
- •no parental consent is obtained
结局指标
主要结局
Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
时间窗: During surgery
Difference between median SpO2/FiO2 ratio in the two groups
次要结局
- Incidence of Postoperative Pulmonary Complications in the first post-operative 24 hours(In the first 24 hours after the intervention/procedure/surgery)
研究者
Anna Camporesi
Principal Investigator
Vittore Buzzi Children's Hospital