Safety, Feasibility and Efficacy of Ventilation Weaning in Children With a Computerized Protocol: a Pilot Study on S1 Ventilator With Intellivent(Hamilton Medical).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Time in acceptable breathing range
研究概览
简要总结
The present protocol will demonstrate the safety, feasibility and efficacy of a newly computerized protocol integrated into a ventilator: S1 ventilator (Hamilton Medical). During ventilation with S1 ventilator, the respiratory support including oxygenation and CO2 removal parameters are continuously adapted to patient respiratory status using science based rules. The present protocol is designed as a pilot evaluative study where the researchers will evaluate the safety, feasibility and efficacy of ventilating children during the weaning phase with the S1 ventilator for 5 hours, and compare to conventional ventilation.
详细描述
Research Design and Methods
Aim: To demonstrate the safety, feasibility and efficacy of delivering ventilator support in intubated children during the weaning phase with S1 ventilator using CO2 removal and O2 delivery explicit computerized protocol (ECP).
Hypothesis: The computerized explicit protocol implemented in S1 ventilator will better maintain children in a normal oxygen saturation, respiratory rate and ETPCO2 range during the weaning phase when compared to usual care.
Eligible patients: All critically ill children will be considered eligible for this research project if they fulfill all the following criteria :
- The patients should be PICU-hospitalized
- Child under mechanical ventilation with an endotracheal tube for at least 12 hours, as estimated by the attending intensivist.
- Child below 18 years of age, with a body weight ≥ 3 kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An eligible subject will be considered for inclusion into this clinical trial if the attending physician is ready to begin weaning from mechanical ventilation and if the patient fulfils all the following inclusion criteria:
- •The attending physician thinks that the patient will be able to breathe spontaneously or the patient is already breathing spontaneously.
- •No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine or dobutamine (≤ 5 µg/kg/min)
- •Slight or no endotracheal tube gas-leakage ((Vti - Vte)/Vti ≤ 20%)
- •Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP
- •PEEP ≤ 8 cmH2O
- •FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%
- •PaCO2 < 70 mmHg on the last blood gases
- •Extubation not expected the day of inclusion
- •Gap between ETPCO2 and PCO2 < 7 mmHg on last blood gas.
排除标准
- •A patient will be excluded from this study a priori if he/she presents one or many of the following criteria:
- •The patient fails the pressure-support test (this test is described below in the section entitled "Intervention").
- •Invasive or non invasive mechanical ventilation at home or on hospital ward before PICU admission.
- •Child with a tracheotomy
- •Child with an history of mechanical ventilation > 2 months
- •Contemplate withdrawing mechanical ventilation for palliative care
- •Child with tracheobronchomalacia responsible for chronic respiratory failure
- •Child with a severe neuromuscular disease prior to admission or acquired in the PICU and unable to generate a negative pressure of at least - 20 cmH20 during inspiration.
- •Child with a "do not resuscitate order" and/or "do not reintubate order" is prescribed
- •The child is still receiving some curare
- •Cyanotic congenital heart disease with unrepaired or palliated right to left intracardiac shunt.
- •Primary pulmonary hypertension.
- •Child not expected to survive within a week, according to the attending intensivist
- •Brain death or suspected brain death
- •Morbid obesity defined by a body mass index (Actual Body Weight/T² > 40)
- •Pregnant patient
- •Parents or tutors do not agree to sign the consent form
- •S1 ventilator is not available
- •SpO2 monitoring not available (no plethysmographic curve) or not reliable
- •EtCO2 not available (no capnogram) or no reliable (see above "gap")
结局指标
主要结局
Time in acceptable breathing range
时间窗: one hour
Normal breathing range is defined as: In children age ≤ 2 years old: RR between 15 and 60 bpm and a tidal volume above 5 ml/kg of ideal body weight. In children \> 2 years old: RR between 10 and 50 bpm and a tidal volume above 5 ml/kg of ideal body weight.
次要结局
- Time in acceptable saturation range(1 hour)
研究者
Philippe Jouvet
Associate Professor
St. Justine's Hospital