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IRCT20220215054026N1 IRCT 2022-12-17 Sanandaj University of Medical Sciences ŮŽAssessing the effect of an oral hygiene protocol on ventilator associated pneumonia among the intubated patients hospitalized in Intensive care units ŮŽAssessing the effect of an oral hygiene protocol on ventilator associated pneumonia among the intubated patients hospitalized in Intensive care units 2016-06-01 anticipated 200 Complete https://irct.ir/trial/62234 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients into the intervention and control groups will be done by permuted block randomization (block size=4 ). Since the block size in our study is four, we can make six possible sequences as follows; AABB, ABAB, ABBA, BAAB, BABA, BBAA The allocator will hide the block size from the executer and will use randomly mixed block sizes to prevent the prediction of the next assignment by executer and outcome assessor, Blinding description: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind. In the other words, patients and outcome assessors will be blinded to the intended intervention. According to the condition of the patients (being intubated), written informed consent to enter the study is obtained from the companions or guardians of the patient (father, brother, grandfather, etc.). To ensure blinding by outcome assessors, the oral and dental hygiene protocol (intended intervention) is placed next to the bed of all patients. Also the allocator will hide the block size from the executer and will use randomly mixed block sizes to prevent the prediction of the next assignment by the executer and outcome assessor. N/A Ventilator associated pneumonia. Intervention 1: For the intervention group, in addition to all standard oral care, a supervised implementation of oral health guideline, including seven items will be considered as follows: 1) Wash your hands and then wear gloves. 2) Open the mouth and divide it into 4 quarters so that the oral examination can be done more easily from the upper right quarter to the lower right quarter. Report any abnormal findings such as white or red lesions, abnormal lumps, and halitosis in the form. (If such lesions are observed, nystatin should be prescribed according to the instructions: ten vials of 150,000 units / ml for two weeks / four times a day / two full droppers each time that should stay in the mouth for two minutes). 3) Increase the cuff pressure of the endotracheal tube to more than 20 mmHg while the patient's body is raised to 25 degrees, and then suction the subglottic area. 4) Turn the patient's head laterally and start brushing teeth and tongue, hard palate and gums in toothless patients with a baby toothbrush and toothpaste containing fluoride (not antibacterial). Brushing should be repeated every 8-12 hours for at least 5 minutes in each time. 5) Use normal saline solution to rinse your mouth after brushing and then suction. (You can spray normal saline on the teeth using a syringe)6) Use chlorhexidine gluconate 0.2% to rinse the patient's mouth, throat thoroughly, and suction after 1 to 2 minutes.7) Every 4 hours, apply a moisturizing gel on all the tissues inside the mouth and then apply Vaseline on the lips with a finger. Intervention 2: Control group: The control group will be received all standard oral care (rinsing the mouth with normal saline and mouth and lung suctioning, cleaning the tongue and teeth with gas, rinsing with chlorhexidine 0.2%, and suctioning the rinsing solution). Yes - There is a plan to make this available What will be shared: Effect of oral health care protocol on Ventilator-associated pneumonia When: After publishing the related paper - no time limitation To whom: Researchers Conditions: To use in the systematic review and meta analysis study Where to obtain: By mailing to corresponding author How to obtain: No specific process is needed. It can be available through contacting to the corresponding author Comments:
public Sharare Karimi
Pasdaran Blv.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 dr.karimi.sh@gmail.com Sanandaj University of Medical Sciences scientific Sharare Karimi
Pasdaran Blv.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 dr.karimi.sh@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age >=18 years Patient with no oral trauma Patient with no fracture in the face The patient must be intubated within the first 24 hours of admission. The patient has not been admitted to any other hospital department in the last 48 hours. Patients who are intubated for at least 1 week and at most 3 months. Written informed consent of the patient's guardian or companion (father, brother, grandfather) to participate in the study 18 years no limit Both Observing any injuries in the oral during the study Observinng any facial fracture during the study Patients who can remove the tracheal tube in less than 48 hours. Critically ill patients with life expectancy less than 48 hours J95.851 Ventilator associated pneumonia Prevention Prevention For the intervention group, in addition to all standard oral care, a supervised implementation of oral health guideline, including seven items will be considered as follows: 1) Wash your hands and then wear gloves. 2) Open the mouth and divide it into 4 quarters so that the oral examination can be done more easily from the upper right quarter to the lower right quarter. Report any abnormal findings such as white or red lesions, abnormal lumps, and halitosis in the form. (If such lesions are observed, nystatin should be prescribed according to the instructions: ten vials of 150,000 units / ml for two weeks / four times a day / two full droppers each time that should stay in the mouth for two minutes). 3) Increase the cuff pressure of the endotracheal tube to more than 20 mmHg while the patient's body is raised to 25 degrees, and then suction the subglottic area. 4) Turn the patient's head laterally and start brushing teeth and tongue, hard palate and gums in toothless patients with a baby toothbrush and toothpaste containing fluoride (not antibacterial). Brushing should be repeated every 8-12 hours for at least 5 minutes in each time. 5) Use normal saline solution to rinse your mouth after brushing and then suction. (You can spray normal saline on the teeth using a syringe)6) Use chlorhexidine gluconate 0.2% to rinse the patient's mouth, throat thoroughly, and suction after 1 to 2 minutes.7) Every 4 hours, apply a moisturizing gel on all the tissues inside the mouth and then apply Vaseline on the lips with a finger. Control group: The control group will be received all standard oral care (rinsing the mouth with normal saline and mouth and lung suctioning, cleaning the tongue and teeth with gas, rinsing with chlorhexidine 0.2%, and suctioning the rinsing solution). The occurence of ventilator-associated pneumonia (VAP). Timepoint: After 48 hours of intubation and doing intervention, each patient will be evaluated daily for the occurrence of ventilator-associated pneumonia. Method of measurement: Clinical criteria, the clinical pulmonary infection score (CPIS), that described initially by Johanson et al. And suggested by the Centers for Disease Control and Prevention (CDC), will be used to assess the VAP. This tool consists of clinical, microbiological, physiological and radiographic evidence and allow us a numerical value to predict the presence/absence of VAP . Sanandaj University of Medical Sciences Approved 2016-05-04 Kurdistan University of Medical Sciences Pasdaran St. after Qods hospital Sanandaj Kurdistan Iran (Islamic Republic of)