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Evaluation and comparison of the effects of three oral care programs on oropharyngeal complications and the Occurrence of ventilator associated pneumonia in patients undergoing mechanical ventilation

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History
# Registration date Revision Id
2 2019-11-11, 1398/08/20 111747
1 2019-11-07, 1398/08/16 110212
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  • Recruitment centers

    #1
    Name of recruitment center - English: Isfahan University of Medical Sciences Hospital
    Name of recruitment center - Persian: بیمارستان منتخب دانشگاه علوم پزشکی اصفهان
    Full name of responsible person - English: D.r Hamid Melali
    Full name of responsible person - Persian: دکتر حمید مللی
    Street address - English: Ebn sina Ave
    Street address - Persian: خیابان ابن سینا
    City - English: isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3445 5051
    Fax:
    Email: amin@mui.ac.ir
    Web page address: https://amin.mui.ac.ir
    Name of recruitment center - English: Amin Hospital
    Name of recruitment center - Persian: بیمارستان امین
    Full name of responsible person - English: Dr. Hamid Melali
    Full name of responsible person - Persian: دکتر حمید مللی
    Street address - English: Ebn sina Ave
    Street address - Persian: خیابان ابن سینا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3445 5051
    Fax:
    Email: amin@mui.ac.ir
    Web page address: https://amin.mui.ac.ir
    #2
    Name of recruitment center - English: Alzahra hospital
    Name of recruitment center - Persian: بیمارستان الزهرا
    Full name of responsible person - English: Dr. Majid Rezvani
    Full name of responsible person - Persian: دکتر مجید رضوانی
    Street address - English: Alzahra Medical and Educational Center., Sofeh Boulevard., Shahid Keshvari Highway
    Street address - Persian: بزرگراه شهید کشوری، بلوار صفه، مرکز درمانی آموزشی الزهرا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Fax:
    Email: alzahra@mui.ac.ir
    Web page address: http://alzahra.mui.ac.ir
    #3
    Name of recruitment center - English: Khorshid hospital
    Name of recruitment center - Persian: بیمارستان خورشید
    Full name of responsible person - English: Dr. Ramin Sami
    Full name of responsible person - Persian: دکتر رامین سامی
    Street address - English: Khorshid Medical Educational Research Complex., Ostandari Ave
    Street address - Persian: اصفهان، خیابان استانداری، مراکز آموزشی درمانی خورشید
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8145831451
    Phone: +98 31 3222 2127
    Fax:
    Email: nour@mui.ac.ir
    Web page address: https://nour.mui.ac.ir

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: D.r Shaghayegh Haghjoo javanmard
    Full name of responsible person - Persian: شقایق حق جوی جوانمرد
    Street address - English: hezar jarib Ave
    Street address - Persian: خیابان هزار جریب
    City - English: isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3060
    Fax:
    Email: sh_haghjoo@med.mui.ac.ir
    Web page address: https://research.mui.ac.ir/

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: D.r Shaghayegh Haghjoo javanmard
    Full name of responsible person - Persian: شقایق حق جوی جوانمرد
    Street address - English: Hezar jarib Ave
    Street address - Persian: خیابان هزار جریب
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3060
    Fax:
    Email: sh_haghjoo@med.mui.ac.ir
    Web page address: https://research.mui.ac.ir/

Protocol summary

Study aim
Determination and comparison of the effects of three oral care programs on oropharyngeal complications and the Occurrence of ventilator associated pneumonia in patients undergoing mechanical ventilation
Design
All hospitalized patients with inclusion criteria will be selected and then divided into one of three groups using the statistical software; the study will have two intervention groups and one quasi-intervention group with parallel groups.
Settings and conduct
A clinical trial study on prophylaxis is conducted in Isfahan University of Medical Sciences Hospital without blinding
Participants/Inclusion and exclusion criteria
patient will have an endotracheal tube; Do not have mucosal inflammation or severe trauma to the mouth; Do not have Chronic Disease and Immune Deficiency; Have teeth; Do not have reentubation; Be the first day of patient intubation; No tracheostomy during the study; no apparent aspiration; at least platelet 40,000; at least INR 2; no transfer or discharge prior to day 7; no pneumonia within 48 hours of study
Intervention groups
The three intervention groups included: the first group taking oral care with chlorhexidine solution 0.2% and swab every 12 hours; the second group brushing with chlorhexidine 0.2% every 12 hours; the third group brushing every 6 hours, twice with chlorhexidine 0.2% and twice with normal saline; 12 hours interval; in all three groups oral suctioning, oral cavity moisturizing and lipsticking will be performed every 4 hours
Main outcome variables
pneumonia; oropharyngeal complications; oral care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191012045066N1
Registration date: 2019-11-07, 1398/08/16
Registration timing: registered_while_recruiting

Last update: 2019-11-25, 1398/09/04
Update count: 1
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Samira Ghasemi Gavarti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7500
Email address
samghasemi68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effects of three oral care programs on oropharyngeal complications and the Occurrence of ventilator associated pneumonia in patients undergoing mechanical ventilation
Public title
The effects of oral care program on oropharyngeal complications and the Occurrence of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient will have an endotracheal tube Do not have mucosal inflammation or severe trauma to the mouth Do not have Chronic Disease and Immune Deficiency Have teeth Do not have reentubation Be the first day of patient intubation
Exclusion criteria:
Insertion a tracheostomy for the patient during the study The obvious aspiration Reduce platelet count to less than 40000 Increase INR to more than 2 Transfer or discharge the patient to another ward before the seventh day Diagnose pneumonia within the first 48 hours after mechanical ventilation is started
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, patients with inclusion criteria will be selected one by one. Then, the variables defined for the software, including their age, sex, diagnosis, and chip tube number, are entered into the online minimap software. Software randomly divides patients into one of three groups. Sampling will continue this way until the required number of samples is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib Ave
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.333

Health conditions studied

1

Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia

2

Description of health condition studied
oropharyngeal complications
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Clinical pneumonia infection score
Timepoint
Before the intervention, on the fourth and seventh days of the intervention
Method of measurement
Modified clinical pneumonia infection score

2

Description
Oral Health Score
Timepoint
On the second, fourth and seventh days of the intervention
Method of measurement
Beck Oral Assessment Scale

3

Description
Oral Health Score
Timepoint
On the second, fourth and seventh days of the intervention
Method of measurement
Mucosal Plaque Score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral care with swab and chlorhexidine solution 0.2% every 12 hours and equal care between groups (oral cavity moistening and lipsticking every 4 hours and oral suctioning if needed)...
Category
Prevention

2

Description
Intervention group: Oral care with toothbrush and chlorhexidine solution 0.2% every 12 hours and equal care between groups
Category
Prevention

3

Description
Intervention group: Oral care every 6 hours, twice with toothbrush and 0.2% chlorhexidine solution every 12 hours, twice with toothbrush and normal saline every 12 hours and equal care between groups
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Dr. Hamid Melali
Street address
Ebn sina Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Web page address
https://amin.mui.ac.ir

2

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Majid Rezvani
Street address
Alzahra Medical and Educational Center., Sofeh Boulevard., Shahid Keshvari Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

3

Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Dr. Ramin Sami
Street address
Khorshid Medical Educational Research Complex., Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
https://nour.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
D.r Shaghayegh Haghjoo javanmard
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Haghighat
Position
Senior lecturer- Faculty member of nursing and midwifery colege
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
s_haghighat@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Haghighat
Position
Senior lecturer- Faculty member of nursing and midwifery college
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
s_haghighat@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samira Ghasemi Gavarti
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezar jarib Ave. Medical university isfahan. Nursing and midwifery college.
City
Isfahan
Province
Isfehan
Postal code
8174773461
Phone
+98 31 3792 7500
Fax
Email
Samghasemi68@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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