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IRCT20211010052718N3 IRCT 2023-09-03 Mazandaran University of Medical Sciences Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients. Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients. 2023-02-20 anticipated 150 Complete https://irct.ir/trial/69600 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients after choosing and obtaining informed consent to participate in the study after explaining the steps of conducting the research using the Simple Random Allocation method using a table of random numbers by computer and online (using the website www.random.org/integres) as They were randomly divided into two groups, A and B, each of which had its own code. These codes were written on the final envelope in which the patient group was specified. Without knowing these codes, the research colleagues placed the patients in one of the two groups by selecting each envelope. 3 Diffuse traumatic brain injury. Intervention 1: Intervention group: patients who are ventilated with a laryngeal mask, first the Endotracheal tube(ETT) was removed and then a Laryngeal mask airway(LMA Classic™) (purchased from Saba compani, Iran) or a disposable LMA was implanted. LMA size was 4 in women and 5 in men. Then the LMA was fixed with glue and the patient's head was pulled. Inspiratory pressure was adjusted to reduce excessive air leakage when necessary. The video bronchoscope was inserted into the trachea through the LMA and the thyroid and cricoid cartilages and the upper 3 cartilages of the trachea were identified. After this, the tip of the bronchoscope was placed zero to one centimeter below the vocal cords to observe the thyroid cartilage. Intervention 2: Control method: In patients who are ventilated with a tracheal tube, the cricoid and thyroid cartilages are touched and the position of the first tracheal cartilage is determined. Then the bronchoscope was inserted into the ETT up to the tip of the Endotracheal tube(ETT). After that, the ETT (purchased from Saba compani, Iran) and the bronchoscope were placed directly above the specified position. This step was seen by transillumination and supported by another person responsible for positioning and stabilizing the ETT. Besides inspiratory pressure, ventilation variables were not modified. ETT size in women was 7.5-0.7 mm (inner diameter) and in men 0.8-7.5 mm. Percutaneous dilatational tracheostomy(PDT) was performed according to the Griggs method (31). After cutting the skin, the tracheal hole was guided by bronchoscopy to the midline of the trachea under the first or second tracheal cartilage. With the guidance of the guidewire, the dilatation process was checked with the Griggs dilating forceps and the guidance of the tracheostomy tube was also checked bronchoscopically. Before connecting to the ventilator, the intratracheal position of the cannula was confirmed by tracheobronchoscopy through the tracheostomy tube. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided
public Alireza Nikzad
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 A.NIKZAD@MAZUMS.AC Mazandaran University of Medical Sciences scientific Alireza Nikzad
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 33131 - 48166 +98 11 3336 1700 A.NIKZAD@MAZUMS.AC Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with brain injury hospitalized in the intensive care unit who need long-term respiratory care 20 years no limit Both Patients who had contraindications for Percutaneous DilatedTracheostomy included inadequate and difficult airway Patients who had contraindications forPercutaneous DilatedTracheostomy included obese subjects Patients with contraindications for Percutaneous DilatedTracheostomy included potentially difficult endotracheal intubation Patients with contraindications forPercutaneous DilatedTracheostomy included oxygenation index (Pascal Oxygen2/Fraction of Inspired Oxygen2) less than 200 Patients with contraindications for Percutaneous DilatedTracheostomy included positive end-expiratory pressure (Positive end-expiratory pressure ) ≥15 mbar S06.2X Diffuse traumatic brain injury Treatment - Devices Treatment - Surgery Intervention group: patients who are ventilated with a laryngeal mask, first the Endotracheal tube(ETT) was removed and then a Laryngeal mask airway(LMA Classic™) (purchased from Saba compani, Iran) or a disposable LMA was implanted. LMA size was 4 in women and 5 in men. Then the LMA was fixed with glue and the patient's head was pulled. Inspiratory pressure was adjusted to reduce excessive air leakage when necessary. The video bronchoscope was inserted into the trachea through the LMA and the thyroid and cricoid cartilages and the upper 3 cartilages of the trachea were identified. After this, the tip of the bronchoscope was placed zero to one centimeter below the vocal cords to observe the thyroid cartilage. Control method: In patients who are ventilated with a tracheal tube, the cricoid and thyroid cartilages are touched and the position of the first tracheal cartilage is determined. Then the bronchoscope was inserted into the ETT up to the tip of the Endotracheal tube(ETT). After that, the ETT (purchased from Saba compani, Iran) and the bronchoscope were placed directly above the specified position. This step was seen by transillumination and supported by another person responsible for positioning and stabilizing the ETT. Besides inspiratory pressure, ventilation variables were not modified. ETT size in women was 7.5-0.7 mm (inner diameter) and in men 0.8-7.5 mm. Percutaneous dilatational tracheostomy(PDT) was performed according to the Griggs method (31). After cutting the skin, the tracheal hole was guided by bronchoscopy to the midline of the trachea under the first or second tracheal cartilage. With the guidance of the guidewire, the dilatation process was checked with the Griggs dilating forceps and the guidance of the tracheostomy tube was also checked bronchoscopically. Before connecting to the ventilator, the intratracheal position of the cannula was confirmed by tracheobronchoscopy through the tracheostomy tube. Determining the quality of tracheostomy. Timepoint: Before and after the presser. Method of measurement: Arterial blood gas levels. Comparison of the amount of time of two methods. Timepoint: before and after. Method of measurement: Record the time of the procedure from the beginning to the end. Mazandaran University of Medical Sciences Approved 2022-12-14 Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)