A Randomized Study on the Safety and Tolerability of Mechanical Insufflation-exsufflation and Hypertonic Saline With Hyaluronic Acid for Suctioning of Respiratory Tract Secretions in Patients With Artificial Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.
研究概览
简要总结
Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning.
Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.
详细描述
Secretion suctioning (SS) in patients with artificial airway is a mandatory procedure, although occasionally painful, not tolerated and even causing traumatic injury to the respiratory mucosa.
Mechanical insufflation-exsufflation (MIE) and nebulized hypertonic saline with hyaluronic acid (HS-HA) have shown efficacy and safety in patients with chronic neuromuscular and pulmonary diseases, achieving aspiration and fluidification of respiratory secretions, respectively, as well as good tolerance.
Only anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available.
Background: Both MIE and HS-HA facilitate the drainage of secretions from the distal airway (compared to conventional catheter suctioning, the effect of which is supposed to be limited to the trachea) Both measures may prove to be efficacious in the prevention (through airway clearance of secretions) and concomitant treatment (reduction of inoculum or "draining the lung") of lower respiratory tract infections (tracheobronchitis and pneumonia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Closed envelop to be opened after inclusion/exclusion criteria are met and informed consent obtained
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
- •Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.
- •Need for aspiration of secretions
- •Informed consent
排除标准
- •Macroscopic hemoptysis.
- •Acute bronchospasm
- •Uncrontrolled muscular contractions, like tremor, myoclonus or other.
- •Confirmed pregnancy
研究组 & 干预措施
Catheter secretion suctioning
Secretions are aspirated with a catheter at -120 to -150 mBar
干预措施: Catheter secretion suctioning (Device)
Secretion suctioning + hypertonic saline
Hypertonic saline is nebulized prior to aspiration of secretions.
干预措施: Secretion suctioning + hypertonic saline (Combination Product)
Ins-exsufflation
Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg
干预措施: Ins-exsufflation (Device)
Ins-exsufflation + Hypertonic Saline
Mechanical insufflation-exsufflation and hypertonic saline
干预措施: Ins-exsufflation + Hypertonic saline (Combination Product)
结局指标
主要结局
Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.
时间窗: 1 hour
Comparative sedation/agitation score of the study procedures in the 4 study groups will be assessed using the RASS (Richmond Agitation-Sedation Scale, see citations), range -5, un-arousable, to +5, combative) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline.
时间窗: 1 hour
Comparative incidence of aggregate hemodynamic and respiratory adverse events. Adverse events criteria are predefined and will be expressed as: * Percentage of patients meeting aggregate predefined hemodynamic or respiratory adverse event criteria per study group. * Percentage of specific predefined adverse events (outcome variable "yes" or "no"): Desaturation (pulse-oximetry, \>5%), hemoptisis (yes or no), bronchospasm (needing bronchodilator therapy), pneumothorax (as assessed by chest X-ray), hypotension (\>30% or \>10% increase in noradrenaline infusion from baseline), hypertension (\>30% or \>10% decrease in noradrenaline infusion from baseline), tachycardia (\>90 bpm or \>30% increase), bradycardia (\<40 bpm), arrythmias (supra ventricular, requiring therapy), atelectasis (as assessed by chest X-ray), and other complications occuring during or within 1 hour after the procedure.
Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems.
时间窗: 1 hour
Comparative pain scores of the study procedures in the 4 study groups will be assessed using the "ESCID" pain score (EScala de Conductas Indicadoras de Dolor, ranging from 0, no pain, to \>6, intense pain, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions. Both comparison of the score at the 4 study time-points and their variations between time-points will be analysed.
Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system.
时间窗: 1 hour
Comparative sedation/responsiveness score of the study procedures in the 4 study groups will be assessed using the responsiveness "Ramsay" Sedation Scale, range from 1, anxious and agitated, to 6, no response to stimulus, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
次要结局
未报告次要终点
研究者
Miguel Sanchez Garcia
Director Critical Care. MD. PhD.
Hospital San Carlos, Madrid