The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 5
- 主要终点
- Number of patients in whom a loss of airway has ocurred
研究概览
简要总结
Tracheostomy is one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. However, for others, endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during PT in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the results of six published nation surveys. Extensive randomized trials to compare PT with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis: Percutaneous tracheotomy performed under endoscopic guide decreases the incidence of perioperative complications of the procedure.
详细描述
Background
Tracheostomy is one of the most frequently performed techniques in intensive care units (ICU). A few years after the description of the percutaneous dilatational tracheostomy (PDT), endoscopic guide as part of the technique was performed in four patients. The authors concluded that the endoscopic guide provided advantages to the realization of PDT. Other authors have state that endoscopy, significantly reduces the incidence of serious complications such as posterior tracheal tears, false passage, pneumothorax and subcutaneous emphysema. However, currently endoscopic guide as part of the percutaneous tracheostomy is controversial. Although for some authors its use reduces the number of complications, others found that endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. Thus, some do not consider it necessary when the physicians have enough experience with percutaneous tracheostomy. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during percutaneous tracheostomy in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the published surveys. Specifically, in Spain its use was the lowest of the six published nation surveys. Extensive randomized trials to compare percutaneous tracheostomy with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis
Percutaneous tracheostomy performed under endoscopic control does not reduce the incidence of perioperative complications of the procedure in critically ill patients when it is performed by experienced physicians in patients without anatomical abnormalities.
Main goal
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old requiring tracheotomy due to prolonged mechanical ventilation
- •That Family members or legal representatives have signed the information sheet and informed consent
排除标准
- •Patients with increased intracranial pressure according to intracranial pressure monitoring or suspected.
- •Patients who have any absolute or relative contraindication for the percutaneous tracheostomy realization
- •Patients with difficult airway
结局指标
主要结局
Number of patients in whom a loss of airway has ocurred
时间窗: From randomization until the end of the procedure
Loss of airway: Failure to be able to access the airway \> 30 seconds.
Number of patients with hypotension
时间窗: From randomization until the end of the procedure
Hypotension requiring treatment with vasopressors or \>1000 ml of fluids during the procedure.
Number of patients in whom false passage has ocurred
时间窗: From randomization until the end of the procedure
False passage: Dilatation or insertion of the cannula out of the trachea lumen.
Number of patients in whom cardiac arrest or death directly related to any complication arising from the technique occurred
时间窗: From date of randomization until the ICU discharge
Cardiac arrest or death
Number of patients with posterior tracheal wall injury
时间窗: From date of randomization until 24 hours later
Posterior tracheal wall injury: Injury to membranous trachea by the needle, guide or dilator along with any related consequences (pneumomediastinum, pneumothorax, subcutaneous emphysema, tracheo-esophageal fistula)
Number of patients with bleeding
时间窗: From date of randomization until 24 hours later
Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
Number of patients with hypoxemia
时间窗: From date of randomization until 24 hours later
Hypoxemia: Oxygen arterial saturation (SaO2) \< 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia.
Number of patients with atelectasis
时间窗: From date of randomization until 24 hours later
Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.
Number of patients with barotrauma
时间窗: From date of randomization until 24 hours later
Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
次要结局
- Tidal volume(From randomization until the end of the procedure)
- Oxygen saturation (SaO2)(From randomization until the end of the procedure)
- Peak airway pressure(From randomization until the end of the procedure)
- Plateau pressure(From randomization until the end of the procedure)
- Arterial Blood Gas(From randomization until 15 minutes after the procedure)
研究者
José Manuel Añón
MD,PhD
Instituto de Investigación Hospital Universitario La Paz