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IRCT20201013049017N2 IRCT 2022-09-15 Esfahan University of Medical Sciences Investigating the effect of Lidocaine injection into the airways in order to prevent lung infection Investigating the effect of Lidocaine injection into tracheal lumen in order to prevent pulmonary infection in trauma patients under mechanical ventilation 2022-08-27 anticipated 60 Complete https://irct.ir/trial/64664 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we will use the limited randomization method of the Block randomization type according to gender and age. The size of all the blocks is equal and we will have 6 blocks in this two-group experiment (including 3 participants in the intervention group and 3 participants in the control group). The randomization tool is also used from the random sequence generation software, which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. For concealment, we use random allocation concealment, which refers to the method used to perform a random sequence on the interventionists in the intensive care unit in this study, so that the allocated group is not known before the allocation of the individual. By using sealed opaque mail envelopes with a random sequence, in this method, each random sequence generated is recorded on a card, and the cards are placed in the mail envelopes in order and given to the anesthesiologist. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the start time, based on the order of entry of qualified patients into the study, one of the letter envelopes will be opened in order and the assigned group of that participant will be revealed to the interventionist, Blinding description: The person who is going to inject the drugs into the tracheal lumen won't be informed that if the substance is lidocaine or distilled water and the syringes containing the drug is prepared before. The laboratory expert also has no knowledge about which of the lung secretion samples is related to the control group and which is related to the intervention group. Patients' companions also do not know that lidocaine or distilled water will be given to their patient. 3 Pulmonary infection. Intervention 1: Intervention group: 1 mg per kilogram of body weight of 2% lidocaine without epinephrine will be injected into the tracheal lumen 3 times a day for 72 hours by the project manager. On the morning of the fourth day, a sample of each patient's tracheal secretions will be sent to the laboratory for culture. Intervention 2: Control group: 1 mg per kilogram of body weight of Distilled water will be injected into the tracheal lumen 3 times a day for 72 hours by the project manager. On the morning of the fourth day, a sample of each patient's tracheal secretions will be sent to the laboratory for culture. Yes - There is a plan to make this available What will be shared: Only information relevant to the main outcome can be published with de-identification of individuals and prior permission. When: The access period starts six months after the publication of the results To whom: All data will not be accessible and can only be accessed with the permission of patient's gaurdian for ethical authorities Conditions: These data will be used for further studies about the antimicrobial effect of lidocaine Where to obtain: Parisa Karimian(medical student) 0098 9136038372 karimian_p75@yahoo.com How to obtain: The applicant must submit her/his request in the form of an e-mail and while fully introducing herself, she/he must also state the purpose of obtaining the data. Comments:
public Parisa Karimian
No 11, Eshghi dead end, Baghe no alley, Mohtasham kashani St
Isfahan Iran (Islamic Republic of) 8175888113 +98 31 3624 9973 karimian_P75@yahoo.com Esfahan University of Medical Sciences scientific Hamid Talebzadeh
No 11, Eshghi dead end, Baghe no alley, Mohtasham Kashani St
Isfahan Iran (Islamic Republic of) 8175888113 +98 31 3620 1995 talebzadeh.h@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Being under mechanical ventilation for more than three days Consent of first-degree relative for participating in the study no limit no limit Both Receiving broad-spectrum antibiotics (Fluoroquinolones, 3rd and 4th generation Cephalosporins, Carbapenems, Tazocin and other broad-spectrum antibiotics) within 72 hours before the intervention Pulmonary disease(Asthma/COPD) History of cardiac rhythm or rate disorders J15.9 Unspecified bacterial pneumonia Treatment - Drugs Placebo Intervention group: 1 mg per kilogram of body weight of 2% lidocaine without epinephrine will be injected into the tracheal lumen 3 times a day for 72 hours by the project manager. On the morning of the fourth day, a sample of each patient's tracheal secretions will be sent to the laboratory for culture. Control group: 1 mg per kilogram of body weight of Distilled water will be injected into the tracheal lumen 3 times a day for 72 hours by the project manager. On the morning of the fourth day, a sample of each patient's tracheal secretions will be sent to the laboratory for culture. Pulmonary infection according to laboratory culture samples. Timepoint: before the start of the intervention and 72 hours after the start of the intervention. Method of measurement: Cultivation of pulmonary secretions in laboratory. Extubation time. Timepoint: After the end of the intervention (After 72 hours). Method of measurement: Extubation date. Time of discharge from ICU. Timepoint: After the end of the intervention (After 72 hours). Method of measurement: Date of discharge from ICU. Average CRP level. Timepoint: Before the intervention and 72 hours after the intervention. Method of measurement: CRP test. Average ESR level. Timepoint: Before the intervention and 72 hours after the intervention. Method of measurement: ESR test. Average Hemoglobin level (Hb). Timepoint: Before the intervention and 72 hours after the intervention. Method of measurement: Complete blood count test results. Average White blood cell level (WBC). Timepoint: Before the intervention and 72 hours after the intervention. Method of measurement: Complete blood count test results. Esfahan University of Medical Sciences Approved 2022-04-25 ethics committee of Isfahan university of medical sciences No. 11, Eshghi dead end, Baghe no alley, Mohtashame Kashani st. Isfahan Isfehan Iran (Islamic Republic of)