A Phase 4 interventional study of Endotracheal Tube Insertion and Laryngeal Mask Insertion in Intubation, Intratracheal, Tracheostomy and Laryngeal Masks, sponsored by Bozyaka Training and Research Hospital. Status unknown. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by Bozyaka Training and Research Hospital · Phase 4, Interventional, and Treatment
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.
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).
After the ventilation is provided, arterial blood gas samples will be analyzed at the 3rd, 6th, and 10th minutes and every 5 minutes afterward until the end of the procedure. In both groups, fiberoptic bronchoscopy will assist the procedure and "Duration of the Confirmation of the Incision Site" will be noted. 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 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. This will be recorded as "Preparation Time". Tracheostomy will preferably be performed between the 2nd and 3rd cartilage rings but one upper or lower level will be used if needed (per patients' anatomy). Local anesthesia will be applied for the incision site with 4 ml of local anesthetic solution containing %2 lidocaine and %0,00125 epinephrine. "Procedure Time" will start with skin incision and end with successful ventilation after the tracheostomy cannula cuff is inflated.
Gastric distension, hypoxia, regurgitation, hemodynamic parameters (every 3 minutes), complications, and the number of staff will be recorded. When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with an anteroposterior chest x-ray.
SPSS (Statistical Package for Social Sciences version 24) was used for statistical calculation. Parametric test results were reported as mean and standard deviation and non-parametric test results as number and percentage or median and interquartile range. The compliance of the data to normal distribution was determined by the single sample Kolmogorov-Smirnov test. Normally distributed quantitative data were compared with the independent sample T-Test, quantitative data that did not follow normal distribution were compared with the Mann-Whitney U test. A Chi-square test was used to compare qualitative data.
The significance level was determined as p \<0.05 at the 95% confidence interval for the analyzes.
Bozyaka Training and Research Hospital is the lead sponsor of 50 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Procedure: Endotracheal Tube Insertion · Procedure: Fiberoptic Bronchoscopy · Procedure: Radial Artery Monitoring · Diagnostic Test: Anteroposterior chest x-ray · Diagnostic Test: Arterial Blood Gas Analyses · Drug: Propofol Fresenius · Drug: Rocuronium · Drug: Fentanyl
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)
Procedure: Laryngeal Mask Insertion · Procedure: Fiberoptic Bronchoscopy · Procedure: Radial Artery Monitoring · Diagnostic Test: Anteroposterior chest x-ray · Diagnostic Test: Arterial Blood Gas Analyses · Drug: Propofol Fresenius · Drug: Rocuronium · Drug: Fentanyl
ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords)
After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted.
After the patients' airway is established, the trachea and the process area will be displayed by the physician. The success rate will be increased by performing the procedure with fiberoptic bronchoscopy.
The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way.
When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray.
Hypoxia, acidosis and carbon dioxide increase will be followed
2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started.
0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given.
Also known as: Muscuron
1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.
Arterial Blood Gas Analysis
Monitoring of hypoxia, acidosis, and carbon dioxide
Time frame: Before the procedure
Arterial Blood Gas Analysis
Monitoring of hypoxia, acidosis, and carbon dioxide
Time frame: 3rd minute after ventilation
Arterial Blood Gas Analysis
Monitoring of hypoxia, acidosis, and carbon dioxide
Time frame: 6th minute after ventilation
Arterial Blood Gas Analysis
Monitoring of hypoxia, acidosis, and carbon dioxide
Time frame: 10th minute after ventilation
Arterial Blood Gas Analysis
Monitoring of hypoxia, acidosis, and carbon dioxide
Time frame: When the tracheostomy cannula cuff is inflated
Positioning time
By placing a transverse elevation under the shoulders, the patients' neck will be extended as approprite.
Time frame: Before the procedure
The Reposition Time
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".
Time frame: Before the procedure
The LMA Insertion Time
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"
Time frame: Before the procedure
Duration of the Confirmation of the Incision Site
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
Time frame: Before the procedure
Preparation Time
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
Time frame: Before the procedure
Procedure Time
"Procedure Time" will start with skin incision and end with successful ventilation after tracheostomy cannula cuff is inflated.
Time frame: 15 minutes after the procedure begins
Incidence of gastric distension
Time frame: Throughout the tracheostomy procedure
Incidence of hypoxia
Time frame: Throughout the tracheostomy procedure
Incidence of regurgitation
Time frame: Throughout the tracheostomy procedure
The number of staff needed
Time frame: Throughout the tracheostomy procedure
Heart rate
Time frame: Every 3 minutes during the procedure
Blood pressure
Time frame: Every 3 minutes during the procedure
Pulse oximeter
Time frame: Every 3 minutes during the procedure
No study locations are listed for this record.
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Bozyaka Training and Research Hospital