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Comparative study of the effect of three types of mouthwash "Colistin and Chlorhexidine", "Tobramycin and Chlorhexidine" and "Chlorhexidine alone" in the prevention of ventilator-associated pneumonia in ICU patients

Protocol summary

Study aim
Determining and comparing the effect of three types of mouthwash "Colistin and Chlorhexidine", "Tobramycin and Chlorhexidine" and "Chlorhexidine alone" in the prevention of ventilator-associated pneumonia
Design
The present study is a randomized double-blind clinical trial.
Settings and conduct
This study is a double-blind clinical trial; in order to evaluate the effect of three types of mouthwash "colistin and chlorhexidine", "tobramycin and chlorhexidine" and "chlorhexidine alone" in the prevention of ventilator-associated pneumonia on 96 patients admitted to the intensive care unit of Alzahra Hospital in Isfahan will be performed in 2020-2021.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age over 18 years and under 65 years, no damage to the mouth, jaw, and face, no immunosuppression due to certain drugs or diseases, the patient should be in the first 24 hours of intubation and should wait at least 72 hours for intubation, a clinical score of lung infection less than 6 on arrival, oral health assessment checklist score 10 and less. Exclusion criteria include having cancer and diabetes and chronic obstructive pulmonary disease, have a history of broad-spectrum antibiotic therapy in the last 3 months, performing the cardiopulmonary resuscitation process, and dissatisfaction of him or his companion to participate in the study.
Intervention groups
In the first intervention group, 5 cc of the solution containing colistin with chlorhexidine, in the second intervention group 5 cc of the solution of tobramycin with chlorhexidine, and in the control group 5 cc of the chlorhexidine solution alone will be prescribed 3 times a day for 5 days.
Main outcome variables
Positive culture of the endotracheal tube; positive oral culture; type of microorganisms grown

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N1
Registration date: 2020-09-11, 1399/06/21
Registration timing: prospective

Last update: 2020-09-11, 1399/06/21
Update count: 0
Registration date
2020-09-11, 1399/06/21
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of three types of mouthwash "Colistin and Chlorhexidine", "Tobramycin and Chlorhexidine" and "Chlorhexidine alone" in the prevention of ventilator-associated pneumonia in ICU patients
Public title
The effect of three types of mouthwash "Colistin and Chlorhexidine", "Tobramycin and Chlorhexidine" and "Chlorhexidine alone" in the prevention of ventilator-associated pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No damage to the mouth, jaw and face Oral health assessment checklist score 10 and less Clinical score of lung infection less than 6 on arrival The patient should be in the first 24 hours of intubation and should wait at least 72 hours for intubation No immunosuppression due to certain drugs or diseases
Exclusion criteria:
Having cancer and diabetes and chronic obstructive pulmonary disease Have a history of broad-spectrum antibiotic therapy in the last 3 months Performing the cardiopulmonary resuscitation process Dissatisfaction of him or his companion to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be selected non-randomized, sequential. Then these patients are coded using computer random allocation software, and then the codes are divided into three parts, and each part of the codes will be assigned to a group.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the present study, a sample of mouthwash used in three types of "Colistin and Chlorhexidine", "Tobramycin and Chlorhexidine" and "Chlorhexidine alone" was prepared by a pharmacist. These solutions will be prepared similarly in volume, shape, and smell and will be coded with labels A, B and C. Then these solutions will be given daily to a nurse who is completely unaware of the type of mouthwash. In addition, the partner specialist as well as the Laboratory Analyzer will not be aware of how randomization is performed.
Placebo
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.MUI.MED.REC.1399.118

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
Positive culture of endotracheal tube
Timepoint
Before and 5 days after starting treatment
Method of measurement
Laboratory

2

Description
Positive oral culture
Timepoint
Before and 5 days after starting treatment
Method of measurement
Laboratory

3

Description
Type of microorganisms grown
Timepoint
Before and 5 days after starting treatment
Method of measurement
Laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will receive 5 cc of a pre-prepared solution containing colistin 20 μg/mL (Darupakhsh company) along with chlorhexidine 0.2%(Darupakhsh company) 3 times a day for 5 days. This solution is applied to the mouth and lips, gums, and inside the cheeks using a swab.
Category
Treatment - Drugs

2

Description
Intervention group: Patients in this group will receive 5 cc of a pre-prepared solution containing tobramycin 10 μg/mL (Darupakhsh company) along with chlorhexidine 0.2% (Darupakhsh company) 3 times a day for 5 days. This solution is applied to the mouth and lips, gums, and inside the cheeks using a swab.
Category
Treatment - Drugs

3

Description
Control group: Patients in this group will receive 5 cc of pre-prepared solution containing 0.2% chlorhexidine (Darupakhsh company) alone 3 times a day for 5 days. This solution is applied to the mouth and lips, gums and inside the cheeks using a swab.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mohammadreza Nazer
Street address
Shahid Sharifat Alleyو Chaharbagh Bala Street
City
Isfahan
Province
Isfehan
Postal code
3871399816
Phone
+98 31 3665 1609
Email
dr.mohammadnazer@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.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
Saeed Abbasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostadan Alley, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
3871399812
Phone
+98 31 3665 1609
Email
s_abbasi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Abbasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostadan Alley, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
3871399812
Phone
+98 31 3665 1609
Email
s_abbasi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Abbasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostadan Alley, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
3871399812
Phone
+98 31 3665 1609
Email
s_abbasi@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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