Randomized Controlled Study of Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Standard One.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Number of Attempts Before Entering Trachea
研究概览
简要总结
The study compares the effectiveness of Tiemann and Suction catheters, with regard to attempts to enter the trachea and the time required for the procedure.
详细描述
The population of the study was twenty (20) patients, hospitalized in General and Cardiothoracic ICU, mostly with respiratory failure of various etiologies, the majority of which has complicated with Unit Myoneuropathy. This state confirmed by medical research council (MRC) Sum score which gave a result less than 48/6011 which corresponds to thirteen (13) patients in the total population of the study.
The randomization of the study achieved using the sealed envelopes method and associated with the catheter to be first used in the suction9,10 (Tiemann or suction catheter).
Twenty (20) sealed envelopes were prepared from a team not related to the study. The sealed envelopes had an inside paper with the sign "T" for the first ten (10) envelopes and "N" for the rest ten (10) of them.
When a new patient met the criteria for this study, one sealed envelope was randomly selected to determine the technique would come first: "T" for Tiemann technique or "N" for Suction catheter technique.
Furthermore the following parameters tabulated for each patient:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients with nasogastric tube and spontaneous breathing without artificial airway
- •Inability to mobilize and handle secretions
- •Glasgow Coma Scale (GCS) >12/15
- •PaO2/FiO2 ratio >100
排除标准
- •Active nasal bleeding
- •international normalized ratio (INR)>3
- •Glasgow Coma Scale (GCS) <11/15
- •Facial or basal cranial fractures
- •Tumor in trachea
- •Pregnancy
- •ICU patients with endotracheal tube or tracheostomy tube
结局指标
主要结局
Number of Attempts Before Entering Trachea
时间窗: An average of 15 seconds
We count the required attempts to insert catheter into trachea (number of attempts)
次要结局
- Time to Entering Trachea(An average of 15 seconds)
- Respiratory Rate Immediately After Intervention(Within 2 seconds after catheter withdrawal.)
- Presence of Blood on Catheter Immediately After Each Intervention(Within 2 seconds after catheter withdrawal.)
- Diastolic Blood Pressure Immediately After Each Intervention(Within 2 seconds after catheter withdrawal.)
- Heart Rate Immediately After Intervention(Within 2 seconds after catheter withdrawal.)
- Systolic Blood Pressure Immediately After Each Intervention(Within 2 seconds after catheter withdrawal.)
研究者
Grigoriadis Konstantinos
Physical Therapist
Attikon Hospital