Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872881
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-04-22
Brief Title:
Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy
Sponsor:
Bozyaka Training and Research Hospital
Organization:
Bozyaka Training and Research Hospital
Study Overview
Official Title:
Comparison of Effectiveness of Different Airway Management Methods During Fiberoptic Bronchoscopy Assisted Percutaneous Tracheostomy
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 methodGriggs 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
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
Detailed Description:
Protection of the airway during percutaneous tracheostomy can be achieved with an endotracheal tube ETT or laryngeal mask LMAResearchers 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 GPower 31 software was used Patients will be reviewed for suitability for procedure as stated in the inclusion criteria Patients andor 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 mgkg propofol 06 mgkg rocuronium and 1 mcgkg fentanyl IV and positioning time will be recorded Propofol infusion at the dose of 6 mgkghour will be started Electrocautery will be available Patients will be mechanically ventilated with a controlled mode CMV with 7mlkg tidal volume 15min 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 000125 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 005 at the 95 confidence interval for the analyzes
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 GPower 31 software was used Patients will be reviewed for suitability for procedure as stated in the inclusion criteria Patients andor 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 mgkg propofol 06 mgkg rocuronium and 1 mcgkg fentanyl IV and positioning time will be recorded Propofol infusion at the dose of 6 mgkghour will be started Electrocautery will be available Patients will be mechanically ventilated with a controlled mode CMV with 7mlkg tidal volume 15min 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 000125 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 005 at the 95 confidence interval for the analyzes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None