Feasibility and Safety of Immediate Versus Gradual Decannulation: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- re-insertion of the tracheostomy tube
研究概览
简要总结
The investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate decannulation and gradual decrease in cannula size. Both groups of patients will be monitored after decannulation and in the outpatient clinic for any complications following the procedure.
详细描述
Recruitment of the patients will be demands for decannulation evaluation of different departments in our institution. All patients who will agree to participate in the study and meet the inclusion criteria would undergo three major steps"
- Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria.
- Decannulation:
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient.
In the gradual decannulation group:
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation. 3. Follow up:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients who underwent tracheostomy with the following conditions:
- •1. Tracheostomy tract is established more than 7 days
- •2. Normal vital signs: heart rate 50-100, 90\90% in room air
- •3. Effective cough
- •4. Normal swallows \\ feeding possibility
- •5. # steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.
- •6. Ability of the patient to breath with a capped cannula.
排除标准
- •Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
- •patient with anatomical neck abnormality
- •Pregnant women
研究组 & 干预措施
immediate decannulation
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient
干预措施: Overnight observation (Other)
immediate decannulation
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient
干预措施: Pre-discharge evaluation (Other)
immediate decannulation
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient
干预措施: outpatient clinic follow ups (Other)
immediate decannulation
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient
干预措施: immediate decannulation (Procedure)
Gradual tracheostomy tube decrease
In the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
干预措施: outpatient clinic follow ups (Other)
Gradual tracheostomy tube decrease
In the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
干预措施: Gradual tracheostomy tube decrease (Procedure)
结局指标
主要结局
re-insertion of the tracheostomy tube
时间窗: 7 days
number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation
mechanical ventilation
时间窗: 7 days
number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation
次要结局
- Death from any cause(90 days)
- Respiratory distress(up to 90 fays following decannulation)
- Pneumonia(90 days following decannulation)
研究者
Dr Oded Cohen
Dr Oded Cohen
Kaplan Medical Center