Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush) Danish Title: Bestemmelse af Den Optimale Indstilling for en Teknologi Til Automatisk Fjernelse af Luftvejssekret (Trachflush)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Ability to remove secretion from tube
研究概览
简要总结
Using a new device, the TrachFlush, the aim of this pilot study is to investigate whether secretions can be removed at the patient's current ventilator settings, or whether pressures and durations considered at the maximal end of clinical practice are required, so as to push secretions around the cuff. The study is a pilot study to investigate the settings required to ensure clinical efficacy of the technology, prior to large scale clinical studies.
详细描述
Design:
Prospective, non-controlled, pilot study of the TrachFlush© technology on 20 patients, mechanically ventilated in the intensive care unit.
Study procedure This study is designed to evaluate whether the TrachFlush technology the symptoms associated with need of tracheal suctioning, when applied at the patient's current ventilator settings, or following a change in ventilator settings to the maximal inspiratory pressure and time acceptable in clinical practice. Figure 2 illustrates the protocol procedure. Patients will be studied during mechanical ventilation when on pressure control or pressure support mode. When recruited, and on clinical need for suctioning, the patient will be evaluated to see if they are eligible for the TrachFlush procedure. If the patient is on a volume regulated mode; has an inspiratory time < 1 second; has a value of positive end expiratory pressure >15 cmH2O; has a PaO2 (arterial partial pressure of oxygen)/FiO2 (fraction of inspired oxygen) ratio lower that 100 mmHg, i.e. indicative of severe ARDS (acute respiratory distress syndrome); or has tachycardia defined as >120 bpm then the patient will be considered ineligible for the procedure. As such, the patient will be considered again on the next clinical need for suctioning. On detection of a clinical need for suctioning, and when the patient is eligible for the TrachFlush procedure, the reason for suctioning will be documented - as inadequate oxygenation, rising ventilation pressures with disturbing ventilation pressure waveforms, or audible sounds of secretions. The TrachFlush procedure will then be performed following the 5 steps described below:
- Ventilator settings for inspiratory pressure, positive end expiratory pressure and, for control mode, respiratory rate will be maintained at current clinical values.
- The TrachFlush "button" will be pressed three times over a period of 1 minute, allowing 3 cuff deflations and inflations during 3 non-consecutive inspirations. As the procedure is rapid, no pre-oxygenation will be performed. SpO2 (oxygen saturation) will be monitored continuously and oxygen flushing applied immediately, should oxygenation deteriorate.
- Following this procedure, clinical indications towards the need of suctioning will be re-evaluated and recorded, with two possible outcomes as evaluated by the investigator at the bedside.
i. Success - Clinical state is such that endotracheal suctioning is no longer required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orally intubated and mechanically ventilated
- •Patients for whom it is expected that secretions will be present during their ventilation period, as assessed by clinical evaluation.
排除标准
- •Admission due to tracheal damage, e.g. inhalation trauma.
- •Severe ARDS (acute respiratory distress syndrome), indicated by a PaO2/FiO2 ratio lower than 100 mmHg or PEEP > 15 cmH2O.
- •Circulatory instability indicated by use of vasopressor (Norepinephrine) >0.1 micro gm/kg/min, heart rate >120, arrhythmia other than atrial fibrillation.
- •Patients with agitated delirium.
- •Mechanical ventilation via tracheostomy
- •Mechanical ventilation is provided with a mask or other non-invasive means
- •Pregnancy
结局指标
主要结局
Ability to remove secretion from tube
时间窗: Immediately after the procedure.
Success - clinical state is such that endotracheal suctioning is no longer required; Failure - clinical state has not improved sufficiently.
次要结局
- Patient comfort(Immediately after the procedure)
- Hypoxia(Immediately after the procedure)
- Procedures performed using increased settings.(Immediately after the procedure)
研究者
Anne Højager Nielsen
Head of Research
Hospitalsenheden Vest