Comparison of Effectiveness of Different Airway Management Methods During Fiberoptic Bronchoscopy Assisted Percutaneous Tracheostomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 主要终点
- Positioning time
研究概览
简要总结
Tracheostomy is a vital procedure in the ICU to maintain the airway and prevent complications that may occur due to intubation. It helps reduce the dead space volume, airway resistance and provides comfort to the patients during the weaning from mechanical ventilation. Two methods are widely used in Percutaneous Dilatational Tracheostomy (PDT): The multiple dilation method (Ciaglia) and the Griggs method.Griggs method will be used in the study.
The Griggs Method: A 10-15 millimeter skin incision is made between the level of the second-third tracheal rings. The location of the needle is confirmed by entering the trachea with an injector filled with 2-3 mL saline from the midline and aspirating air. A J-tipped guidewire is advanced through the needle and the needle is removed. A special forceps with a channel at the tip, through which the guidewire can pass is used in this method. The forceps advanced through the guidewire and then subcutaneous tissues and trachea are dilated in one or two steps. When the stoma is large enough to insert the cannula, it is placed in the trachea and fixed.
Patients who will undergo tracheostomy in the ICU will be included in the study and randomly assigned into two groups. Two different methods, endotracheal tube (ET) or laryngeal mask (LMA), will be used during the tracheostomy for airway management. In both methods, fiberoptic bronchoscopy will assist the procedure.
Researchers aim to compare the two airway management methods in terms of complications, procedure time, and the number of staff needed.
详细描述
Protection of the airway during percutaneous tracheostomy can be achieved with an endotracheal tube (ETT) or laryngeal mask (LMA).Researchers aimed to compare the use of ETT and LMA in this prospective, randomized study.
Multiple blood gas analyses will be performed during the procedure. Airway failure rates, total procedure time, the occurrence of gastric distension and regurgitation, number of staff needed, complications (Hypercarbia, hypoxia, etc.), and hemodynamic parameters (Non-invasive blood pressure, pulse oximeter, electrocardiogram) will be compared.
Patients will be divided into two groups with simple randomization. A-priori study with 14 patients suggested 52 patients are needed for statistical significance (G*Power 3.1 software was used). Patients will be reviewed for suitability for procedure as stated in the inclusion criteria. Patients and/or relatives will be informed about the study and informed consent will be obtained. Invasive arterial blood pressure monitoring of the patients will be available. Before the procedure, the patients' fasting period for 6 hours will be completed and the nasogastric catheter will be removed. Arterial blood gas sample will be checked before the procedure begins. By placing a transverse elevation under the shoulders, the patients' neck will be extended as appropriate. Patients will be positioned after induction with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 mcg/kg fentanyl IV, and positioning time will be recorded. Propofol infusion at the dose of 6 mg/kg/hour will be started. Electrocautery will be available. Patients will be mechanically ventilated with a controlled mode (CMV) with 7ml/kg tidal volume, 15/min frequency, and 5 cmH2O PEEP. Preoxygenation will be made with 100% FiO2 for 5 minutes.
ETT Group: ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords).
LMA Group: After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords).
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant patients over 18 years of age
- •Patients who need a tracheostomy
- •Patients whose opening method of tracheostomy is suitable for percutaneous tracheostomy.
排除标准
- •Refusal of the procedure by the patient or her legal representative
- •Patients under the age of 18
- •Body mass index> 35 patient group
- •Patients with a mass in the neck region for any reason
- •Skin infection at the procedure site
- •Coagulopathy
- •Inability to palpate the cricoid cartilage
研究组 & 干预措施
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Endotracheal Tube Insertion (Procedure)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Fiberoptic Bronchoscopy (Procedure)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Radial Artery Monitoring (Procedure)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Anteroposterior chest x-ray (Diagnostic Test)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Arterial Blood Gas Analyses (Diagnostic Test)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Propofol Fresenius (Drug)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Arterial Blood Gas Analyses (Diagnostic Test)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Rocuronium (Drug)
ETT Group
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords). "The Reposition Time" will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Fentanyl (Drug)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Laryngeal Mask Insertion (Procedure)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Propofol Fresenius (Drug)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Fiberoptic Bronchoscopy (Procedure)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Radial Artery Monitoring (Procedure)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Anteroposterior chest x-ray (Diagnostic Test)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Rocuronium (Drug)
LMA Group
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted. "The LMA Insertion Time" will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway" and tracheostomy will be continued with the usual method (ETT cuff will be inflated under the vocal cords)
干预措施: Fentanyl (Drug)
结局指标
主要结局
Positioning time
时间窗: Before the procedure
By placing a transverse elevation under the shoulders, the patients' neck will be extended as approprite.
The Reposition Time
时间窗: Before the procedure
The Reposition Time will start with the cuff deflation and end with successful ventilation after repositioning. If the ETT can not be repositioned within 5 minutes, it will be considered as a "Failed Airway".
Preparation Time
时间窗: Before the procedure
Area will be cleaned with iodide skin antiseptic, covered with a sterile cover and surgical tools and tracheostomy kit will be prepared for the procedure
Arterial Blood Gas Analysis
时间窗: When the tracheostomy cannula cuff is inflated
Monitoring of hypoxia, acidosis, and carbon dioxide
Duration of the Confirmation of the Incision Site
时间窗: Before the procedure
The bronchoscopy period will start when the physician who will perform the bronchoscope takes the bronchoscope in his hand and ends with the confirmation of the incision site
The LMA Insertion Time
时间窗: Before the procedure
The LMA Insertion Time will start with the cuff deflation of the ETT and end with successful ventilation after LMA insertion. If the LMA cannot be inserted in 3 attempts, it will be considered as a "Failed Airway"
Procedure Time
时间窗: 15 minutes after the procedure begins
"Procedure Time" will start with skin incision and end with successful ventilation after tracheostomy cannula cuff is inflated.
次要结局
- Incidence of hypoxia(Throughout the tracheostomy procedure)
- Incidence of gastric distension(Throughout the tracheostomy procedure)
- Incidence of regurgitation(Throughout the tracheostomy procedure)
- The number of staff needed(Throughout the tracheostomy procedure)
- Heart rate(Every 3 minutes during the procedure)
- Blood pressure(Every 3 minutes during the procedure)
- Pulse oximeter(Every 3 minutes during the procedure)
研究者
Elif Göktaş
Anesthesiology Resident
Bozyaka Training and Research Hospital