Comparison of early and late tracheostomy in the outcome of multitrauma intubated patients
Design
This study is a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups, without control group and phase 1-2 and with the participation of 80 trauma patients candidates for tracheostomy referred to Imam Reza Hospital.
Settings and conduct
In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery by one of the two methods of early and late tracheostomy after random allocation in the two mentioned groups. Early tracheostomy is defined as performing tracheostomy during the first seven days of mechanical ventilation and late tracheostomy is also defined as performing tracheostomy after seven days of intubation.
Participants/Inclusion and exclusion criteria
The inclusion criteria: trauma patients, the duration of ventilation is more than 48 hours and the duration of mechanical ventilation is estimated by the doctor to be at least more than 21 days, and the exclusion criteria: severe injuries to the chest or neck , burns in the neck and patients will be drowned.
Intervention groups
Patients will undergo surgery by one of the two methods of early and late tracheostomy after random allocation in the two mentioned groups. Early tracheostomy is defined as performing tracheostomy during the first seven days of mechanical ventilation and late tracheostomy is also defined as performing tracheostomy after seven days of intubation.
Main outcome variables
Successful weaning from mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N38
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-19, 1402/09/28
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early and late tracheostomy in the outcome of multitrauma intubated patients
Public title
Comparison of early and late tracheostomy in the outcome of intubated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma patients
Duration of ventilation more than 48 hours
Estimated duration of mechanical ventilation by the doctor at least more than 21 days
Exclusion criteria:
Severe injuries to the chest or neck
Burns in the neck
Drowning patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.TBZMED.REC.1402.035
Health conditions studied
1
Description of health condition studied
Successful weaning from mechanical ventilation
ICD-10 code
Z93.0
ICD-10 code description
Tracheostomy status
Primary outcomes
1
Description
Weaning from mechanical ventilation
Timepoint
Once during the study
Method of measurement
Clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will undergo surgery by early tracheostomy after random allocation in the mentioned group. Early tracheostomy is defined as performing tracheostomy during the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded.
Category
Prevention
2
Description
Control group: Patients will be subjected to late tracheostomy surgery after random allocation in the mentioned group. Late tracheostomy is defined as performing tracheostomy after the first seven days of mechanical ventilation. The success rate of weaning from mechanical ventilation for these patients will be recorded.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Shahid Madani Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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