Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients.
Comparison of percutaneous dilatation tracheostomy (PDT) using laryngeal mask airway (LMA) with intubation method in brain trauma (TBI) patients
Design
A controlled, parallel-group, open-label, randomized, phase 2 clinical trial on 150 patients. The software of the website: www.random.org was used for randomization.
Settings and conduct
This study will be a prospective open label randomized clinical trial with that will be conducted by the ethics committee of Mazandaran University of Medical Sciences. After providing informed written consent, all patients assigned for transcutaneous trachesotomy were randomly divided into 2 groups using tracheal tube (control group) or laryngeal mask (intervention group) at Imam Khomeini Hospital in Sari city. Randomization will be achieved by a random list generated by a computer. For randomization, the rand function of Excel software was used. The patient information is collected by the nurse or the ward's secretary and then the information is delivered to the statistical specialist for analysis without the type of patient group.
Participants/Inclusion and exclusion criteria
Brain-injured patients admitted to the intensive care unit requiring long-term respiratory care Patients with contraindications for PDT include an inadequate and difficult airway, potentially difficult endotracheal intubation, oxygenation index less than 200, and Positive end expiratory pressure (PEEP) ≥15 mbar will be excluded from the study
Intervention groups
Control group: patients who are ventilated with a tracheal tube
Intervention group: patients who use a larynx mask in their ventilation
Main outcome variables
Visualization of intratracheal structures during tracheostomy placement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211010052718N3
Registration date:2023-09-03, 1402/06/12
Registration timing:registered_while_recruiting
Last update:2023-09-03, 1402/06/12
Update count:0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
alireza nikzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 3539
Email address
a.nikzad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients.
Public title
Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with brain injury hospitalized in the intensive care unit who need long-term respiratory care
Exclusion criteria:
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
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences
Street address
Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1401.052
Health conditions studied
1
Description of health condition studied
Diffuse traumatic brain injury
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Determining the quality of tracheostomy
Timepoint
Before and after the presser
Method of measurement
Arterial blood gas levels
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Medical Center
Full name of responsible person
Alireza Nikzad
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
A.NIKZAD@MAZUMS.AC
Web page address
http://mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
http://mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alireza Nikzad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
A.NIKZAD@MAZUMS.AC
Web page address
http://mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alireza Nikzad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
A.NIKZAD@MAZUMS.AC
Web page address
http://mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Alireza Nikzad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
A.NIKZAD@MAZUMS.AC
Web page address
http://mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available