Investigating the effect of Lidocaine injection into tracheal lumen in order to prevent pulmonary infection in trauma patients under mechanical ventilation

Determining the effect of lidocaine injection in tracheal lumen on prevention of pulmonary infection in trauma patients under mechanical ventilation

Randomized clinical trial with a control group, double-blind, randomized with rand (Excel) and randomized, with a sample size of 60 people.

In the 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, in the control group, the same amount of distilled water will be injected in the same period of time. On the morning of the fourth day, a sample of each patient's tracheal secretions will be sent to the laboratory for culture by an expert from the laboratory who is not aware of the intervention. The study is double-blinded (participants and Clinical caregiver ).

Entry: being under mechanical ventilation for more than three days, not receiving broad-spectrum antibiotics (fluoroquinolones, 3rd and 4th generation cephalosporins, carbapenems, tazosin and other broad-spectrum antibiotics) within 72 hours before the intervention, consent of companions First degree for participating in the study Failure to enter: pulmonary disease (asthma, and COPD) and heart rhythm and rate disorders in the history taken from the patient's family

Lidocaine without epinephrine will be injected into tracheal lumen of ​​the patients of the intervention group for three days, and distilled water will be injected into the tracheal lumen of ​​the patients of the control group during the same period. On the morning of the fourth day, samples of tracheal secretions will be taken from all the patients in order to compare the two groups in terms of pulmonary infection.

Reduction of pulmonary infection

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.

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.

Only information relevant to the main outcome can be published with de-identification of individuals and prior permission.

The access period starts six months after the publication of the results

All data will not be accessible and can only be accessed with the permission of patient's gaurdian for ethical authorities

These data will be used for further studies about the antimicrobial effect of lidocaine

Parisa Karimian(medical student) 0098 9136038372 karimian_p75@yahoo.com

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.