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IRCT20120605009948N7 IRCT 2019-09-10 Tabriz University of Medical Sciences Hypothyroidism in mechanical ventilation Difficult weaning of mechanical ventilation due to hypothyroidism 2017-02-19 anticipated 80 Complete https://irct.ir/trial/41486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals with inclusion criteria were recruited by a non-random sample method. Then, random allocation was done to form study groups. In this study, a block randomization method (including quadruple blocks) was used. One of non-blinded colleagues of this study, named the catheter implantation method with the letters A and B. Then, the researcher distributed A and B envelopes among patients in a randomized block method for participating in the study. Then, selecting the blocks was continued until achieving the sample size. The method of making random sequence was done using a simple randomization. To make a random sequence for the possible blocks, (6 blocks) we gave numbers to them from 1 to 6. Regarding the sample size, the required quadruple number of blocks was used. The number of blocks was chosen from the random numbers table and based on these numbers the sequence of blocks in each group was identified, Blinding description: In this study, blinding was carried out as follows: The data collector : because of the lack of information about the prescription or not of levothyroxine was blinded. Patients were blinded: because they were not supposed to be aware of the levothyroxine prescription Blinding/Blindfolding Method: Based on the sequence of random numbers, the groups A or B were placed inside sealed envelopes. A researcher who was not aware of the contents and sequence of the envelopes respectively opened the envelopes, and depending on whether they were A or B, levothyroxine was prescribed for them or not. Only one member of team knew A or B was according to which catheter implantation method. 3 Hypothyroidism. Intervention 1: Intervention group: Levothyroxine prescription at a daily dose of 0.1 mg through the nasogastric tube until extubation (Sodium levothyroxine tablet, Iran hormone product). Intervention 2: Control group: Non-prescribed levothyroxine. 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 We have not yet set a conclusion
public Mahid Montazer Bavil
Daneshghah Street
Tabriz Iran (Islamic Republic of) 5166615556 +98 41 3335 7852 montazerma@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Majid Montazer Bavil
Daneshghah Street
Tabriz Iran (Islamic Republic of) 5166615556 +98 41 3335 7852 montazerma@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients without previously known thyroid disease Mechanical ventilation more than one week no limit no limit Both Brain and lung diseases History of interfering drugs with thyroid consumption such as Lithium Patient dissatisfaction History of heart diseases Arrhythmia without cause Patients with history of Hypothyroidism E03 Other hypothyroidism Treatment - Drugs N/A Intervention group: Levothyroxine prescription at a daily dose of 0.1 mg through the nasogastric tube until extubation (Sodium levothyroxine tablet, Iran hormone product) Control group: Non-prescribed levothyroxine Weaning time. Timepoint: Daily. Method of measurement: Using the questionnaire. Tabriz University of Medical Sciences Approved 2017-02-16 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences., Golgasht St., Azadi St Tabriz East Azarbaijan Iran (Islamic Republic of)