To determine the effectiveness of an oral health care protocol in the prevention of ventilator-associated pneumonia
Design
A multicenter interventional study with a control group, double-blind, randomized, which is conducted in a parallel design on 200 patients (100 patients in each of the intervention and control groups). Patients are allocated to intervention and control groups using the permuted block randomization (Block size=4).
Since the block size is four, we can make six possible sequences; these are AABB, ABAB, ABBA, BAAB, BABA, BBAA
Settings and conduct
This multicenter clinical trial is conducted in the intensive care units of three hospitals in western Iran. The hospitals include Besat Hospital in Sanandaj (Kurdistan Province) and Taleghani and Imam Reza Hospitals in Kermanshah (Kermanshah Province).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age >= 18 years
No trauma in the mouth area
Intubation during the first 24 hours of arrival
Intubation period of at least one and maximum 12 weeks,
No hospitalization in any other hospitals during the last 48 hours
Exclusion criteria:
Patients with oral trauma or any facial fractures
Patients who have the possibility of endotracheal tube removal in less than 48 hours
Sever patients (with the possibility of death within 48 hours),
Intervention groups
Intervention group: an evidence-based protocol for oral care
Control group: routine oral health care
Main outcome variables
Incidence of ventilator-associated pneumonia (VAP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220215054026N1
Registration date:2022-12-17, 1401/09/26
Registration timing:retrospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Sharare Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7228
Email address
dr.shkarimi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-01, 1395/03/12
Expected recruitment end date
2017-06-01, 1396/03/11
Actual recruitment start date
2017-06-01, 1396/03/11
Actual recruitment end date
2017-06-01, 1396/03/11
Trial completion date
2017-06-01, 1396/03/11
Scientific title
َAssessing the effect of an oral hygiene protocol on ventilator associated pneumonia among the intubated patients hospitalized in Intensive care units
Public title
َAssessing the effect of an oral hygiene protocol on ventilator associated pneumonia among the intubated patients hospitalized in Intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Pasdaran St. after Qods hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.MUK.REC.1395.59
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
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 .
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital of Kermanshah
Full name of responsible person
Ensi Koliaei
Street address
Blv. Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
nc.kolyaei@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Ensi Koliaei
Street address
Blv. Razi
City
Kermanshah
Province
Kermanshah
Postal code
75333 - 67427
Phone
+98 83 3427 6301
Email
nc.kolyaei@gmail.com
3
Recruitment center
Name of recruitment center
Besat hospital of Kurdistan
Full name of responsible person
Ensi Koliaei
Street address
St. of Keshavarz
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3328 5912
Email
nc.kolyaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blv.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sharare Karimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blv.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
dr.karimi.sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sharare Karimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blv.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
dr.karimi.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sharare Karimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blv.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
dr.karimi.sh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effect of oral health care protocol on Ventilator-associated pneumonia
When the data will become available and for how long
After publishing the related paper - no time limitation
To whom data/document is available
Researchers
Under which criteria data/document could be used
To use in the systematic review and meta analysis study
From where data/document is obtainable
By mailing to corresponding author
What processes are involved for a request to access data/document
No specific process is needed. It can be available through contacting to the corresponding author