Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Weight of endotracheal suctioning
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.
详细描述
After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied.
Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen).
The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques.
In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation < 85%, heart rate > 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children at invasive mechanical ventilation for more than 24 hours;
- •Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score <10 and without a cough reflex);
- •Endotracheal suctioning in a period > 2h before the application of the technique.
排除标准
- •Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
- •Hemodynamic instability (hypotension refractory to treatment)
- •Need of frequent endotracheal suctioning
研究组 & 干预措施
Endotracheal suctioning without expiratory pause
Conventional endotracheal suctioning in closed suction system
干预措施: Endotracheal suctioning without expiratory pause (Other)
Endotracheal suctioning with expiratory pause
Endotracheal suctioning in closed suction system associated with expiratory pause maneuver
干预措施: Endotracheal suctioning with expiratory pause (Other)
结局指标
主要结局
Weight of endotracheal suctioning
时间窗: Immediately after suctioning
Weight of endotracheal suctioning in milligrams
次要结局
- Tidal volume(Baseline and 30 minutes)
- Airway resistance(Baseline and 30 minutes)
- Plateau pressure(Baseline and 30 minutes)
- Peak inspiratory pressure(Baseline and 30 minutes)
- Dynamic compliance(Baseline and 30 minutes)
- Auto-positive end-expiratory pressure (auto-PEEP)(Baseline and 30 minutes)