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IRCT20231009059672N1 IRCT 2023-10-19 Tehran University of Medical Sciences Evaluation of the results of reducing the time of the first tracheostomy tube change in children 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 2021-09-22 anticipated 40 Complete https://irct.ir/trial/73097 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Condition 1: Respiratory failure. Condition 2: Upper respiratory tract obstruction. Condition 3: Prolong intubation. Intervention 1: Control group: The first change of the tracheostomy tube on the 7th day. Intervention 2: Intervention group: First change of tracheostomy tube on the 3rd day. Yes - There is a plan to make this available What will be shared: 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 access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: 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 Where to obtain: Zeynab Agahi Kesheh M.D z_a_k_1991@yahoo.com 00989307805236 How to obtain: 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 Comments:
public Zeynab Agahi Kesheh
4th Floor, Vali Asr Building, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2393 z_a_k_1991@yahoo.com Tehran University of Medical Sciences scientific Fatemeh Mir Ashrafi M.D
4th Floor, Vali Asr Building, Imam Khomeini Hospital Complex, Tohid Squre
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2393 F-mirashrafi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 1 day 15 years Both Lack of parental consent Tracheostomy performed by a service other than ENT Performing tracheostomy outside the children's medical center J96 J39 Respiratory failure, not elsewhere classified Other diseases of upper respiratory tract Other Other Control group: The first change of the tracheostomy tube on the 7th day Intervention group: First change of tracheostomy tube on the 3rd day 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. 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. Length of stay in ICU. Timepoint: Length of stay in ICU after tracheostomy. Method of measurement: Clinical visit. Duration of hospitalization. Timepoint: Hospitalization period after tracheostomy. Method of measurement: Clinical visit. Duration of sedation after surgery. Timepoint: After tracheostomy until the cessation of sedative drugs. Method of measurement: Clinical visit. Discharge status. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit. Time of decannulation. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit. Research and Technology Vice-Chancellor Approved 2022-08-17 Research Ethics Committee of Children's Medical Center/Tehran University of Medical Sciences Children's Medical Center, No 62, Dr Gharib St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)