Evaluation of the results of reducing the time of the first tracheostomy tube change from seven days to three days in one-day to fifteen year old children
Determining the results of reducing the time of the first tracheostomy tube exchange from 7 days to 3 days in children from one day to 15 years old
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized by block randomization method, on 40 patients. A table of random numbers was used for randomization.
Settings and conduct
After performing a tracheostomy in the operating room of the Children's Medical Center (subcutaneous injection of lidocaine-epinephrine solution 1/100000 1cm below the cricoid; transverse skin incision in the midline, longitudinal dissection of the strap muscles in the midline; longitudinal incision between the 2-4 rings of the trachea; stay a suture is applied and the single cannula tube is fixed with two bands) according to the randomized block table, the patients are divided into two groups, control and intervention, and the parents are unaware of which group is intervention or control. All post-operative care in two groups It is done in the same way.
Participants/Inclusion and exclusion criteria
Children aged one day to 15 years who underwent tracheostomy at the Children's Medical Center in the ENT Service and their parents gave written consent to their children's participation in this study.
Intervention groups
The tracheostomy tube of the control group was changed on the 7th day after the operation and the intervention group on the 3rd day.
Main outcome variables
Possible common complications related to tracheostomy & its change; The effects of reducing the time of changing the first tracheostomy tube on the length of stay in ICU & hospital and the duration of receiving sedatives after tracheostomy; The relationship between common complications of tracheostomy & the day of change based on the indication of tracheostomy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231009059672N1
Registration date:2023-10-19, 1402/07/27
Registration timing:retrospective
Last update:2023-10-19, 1402/07/27
Update count:0
Registration date
2023-10-19, 1402/07/27
Registrant information
Name
Zeynab Agahi Keshe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2393
Email address
z_a_k_1991@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2023-03-18, 1401/12/27
Actual recruitment start date
2022-08-17, 1401/05/26
Actual recruitment end date
2023-09-22, 1402/06/31
Trial completion date
empty
Scientific title
Evaluation of the results of reducing the time of the first tracheostomy tube change from seven days to three days in one-day to fifteen year old children
Public title
Evaluation of the results of reducing the time of the first tracheostomy tube change in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between one day and 15 years
Perform tracheostomy by ENT service
Presence of tracheostomy indication
Tracheostomy in children's medical center
Consent of the patient's parents to participate in the study
Exclusion criteria:
Lack of parental consent
Tracheostomy performed by a service other than ENT
Performing tracheostomy outside the children's medical center
Age
From 1 day old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain the balance between the two groups, the block randomization method will be used. So that 10 blocks of four people will be formed and 5 blocks will be assigned to each studied group. Also, a table of random numbers will be used to assign people to each block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the patient's parents do not know the time difference of the first tracheostomy tube change and the doctor is aware of this issue, this study is a blind strain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Children's Medical Center/Tehran University of Medical Sciences
Street address
Children's Medical Center, No 62, Dr Gharib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
IR.TUMS.CHMC.REC.1401.106
Health conditions studied
1
Description of health condition studied
Respiratory failure
ICD-10 code
J96
ICD-10 code description
Respiratory failure, not elsewhere classified
2
Description of health condition studied
Upper respiratory tract obstruction
ICD-10 code
J39
ICD-10 code description
Other diseases of upper respiratory tract
3
Description of health condition studied
Prolong intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Short-term complications after tracheostomy (such as bleeding, expansion of air in the interstitium, obstruction of the tracheostomy tube, accidental decannulation)
Timepoint
The first week after tracheostomy
Method of measurement
Clinical visit
2
Description
Long-term complications after tracheostomy (such as wound complications around the tracheostomy site, granulation tissue around the stoma)
Timepoint
From one week after tracheostomy for at least 3 months
Method of measurement
Clinical visit
3
Description
Length of stay in ICU
Timepoint
Length of stay in ICU after tracheostomy
Method of measurement
Clinical visit
4
Description
Duration of hospitalization
Timepoint
Hospitalization period after tracheostomy
Method of measurement
Clinical visit
5
Description
Duration of sedation after surgery
Timepoint
After tracheostomy until the cessation of sedative drugs
Method of measurement
Clinical visit
6
Description
Discharge status
Timepoint
Patient follow-up up to 3 months after tracheostomy
Method of measurement
Clinical visit
7
Description
Time of decannulation
Timepoint
Patient follow-up up to 3 months after tracheostomy
Method of measurement
Clinical visit
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The first change of the tracheostomy tube on the 7th day
Category
Other
2
Description
Intervention group: First change of tracheostomy tube on the 3rd day
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Fatemeh Mir Ashrafi M.D
Street address
Children's Medical Center, No62, Dr Gharib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2051
Fax
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Web page address
https://enchmc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
The headquarters of Tehran University of Medical Sciences, 6th floor, corner of Qods st, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3125
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Checklist containing demographic information, indication of tracheostomy, short and long-term complications, duration of patient's stay in ICU and hospital, duration of receiving sedative drugs, and discharge status.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to the data in order to know the details of the data related to each participant
Not to be used in a separate study without the knowledge and coordination of the researcher
Non-disclosure of data without the researcher's knowledge and coordination
Conducting independent statistical analyzes on data in separate studies without the knowledge and coordination of the researcher
What processes are involved for a request to access data/document
Data request in email format
Sending study records
A detailed explanation of the reason for the need to access the data
A detailed explanation of how the data will be used
Check the description by the relevant team
Deciding on the possibility of sharing data
If the study team agrees, send the data to the requester