Protocol summary

Study aim
Determination of the effect of oropharyngeal decontamination with local antibiotics on the frequency of ventilator-associated pneumonia in trauma patients in intensive care unit
Design
The study is a double-blind, clinical trial that consists of two groups of intervention and control.Participants will be selected on a 100-person, based on the inclusion and exclusion criteria, and will be assigned to the groups in a simple random manner. participants are selected from hospitalized patients in the intensive care units of Khatam al-Anbia hospital in Zahedan.
Settings and conduct
In this study, 100 patients were selected from traumatic patients admitted to the intensive care unit of Khatam-ol-Anbia hospital in Zahedan who were eligible and randomly divided into two groups of 50, using colored cards. The person in charge of oral care, department staff, expert researcher and a laboratory associate are not aware of how to drive randomization , solution with volume as much as and looks similar to the drug solution used in the intervention group. The intervention starts from the first day after intubation and lasts for at least 3 and up to 5 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 65 years ; Perform intubation in the first 24 hours and wait at least 72 hours ; Clinical pulmonary infection score less than 6 at the time of arrival; Oral hygiene assessment checklist score 10 or less ; GCS less than 9. Non-compliance criteria: Damage to the mouth, jaw and face; Lack of cancer and diabetes and chronic obstructive pulmonary disease; immunosuppression due to certain medications or diseases; history of broad-based antibiotic therapy in the past 3 months;perform a cardiopulmonary resuscitation process.
Intervention groups
The intervention group patients in addition to usual care, including oral care with normal saline four times a day, will be received a pre-compounded solution with 2% concentration of nystatin, poly-myxin and neomycin after washing with normal saline in the oral cavity. The control group is 50 patients. In addition to routine care, normal saline mouthwash four times a day, will be rinsed with a solution that is similar in size and appearance to the intervention, four times a day.
Main outcome variables
Ventilator associated pneumonia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180110038298N1
Registration date: 2018-02-23, 1396/12/04
Registration timing: registered_while_recruiting

Last update: 2018-02-23, 1396/12/04
Update count: 0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Morteza Barani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
m.barani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-07-16, 1397/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oropharyngeal decontamination by topical antibiotics on incidence of ventilator-associated pneumonia in hospitalized traumatic patients in intensive care units
Public title
Effect of oropharyngeal decontamination by topical antibiotics on the ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is between 18 and 65 years Perform intubation in the first 24 hours and stay at least 72 hours Clinical pulmonary infection score less than 6 at the time of arrival Oral hygiene assessment checklist score 10 or less GCS less than 9
Exclusion criteria:
damage to the mouth, jaw and face cancer and diabetes and chronic obstructive pulmonary disease immunosuppression due to certain medications or diseases history of broad-based antibiotic therapy in the past 3 months perform a cardiopulmonary resuscitation process
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
More than 1 sample in each individual
Number of samples in each individual: 4
Tracheal and pharyngeal secretions samples are collected and cultured before intervention in both groups. After the end of the intervention, in each group, the tracheal and throat secretions were collected and cultured in the groups.
Randomization (investigator's opinion)
Randomized
Randomization description
At first, patients will be selected from eligible people with valid entry criteria and then assigned to two groups of intervention and control in a simple random manner. The randomization will be as follows: 100 cards (corresponding to the estimated sample size) are colored with green and orange colors. Green cards are assigned to the control group and 50 red cards for the intervention group. Cards are arranged randomly. After referring to the department and examining the patient and determining his eligibility, depending on the color of card is assigned to each patient, the control group or intervention is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only researcher will be aware of the randomness. In order to blindness, a nurse familiar with critical care , after education about the method of mouthwash and the use of tools, recruitment as a partner who is not familiar with how to allocate patients in the intervention or control group. The solution is uniform and looks similar to the drug solution is provided and give to the nurse for the control group. Proficient collaborator and Samples analyzer lab will not be aware of the randomness.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical Sciences
Street address
NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , university of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR. ZAUMS. REC.1396.290

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 incidence of ventilator-dependent pneumonia
Timepoint
At the beginning of the study, before the intervention, and daily until the end of the intervention
Method of measurement
Clinical pulmonary infection score

Secondary outcomes

1

Description
Microorganisms grown from pharyngeal and tracheal secretion samples
Timepoint
The first day of the study before the intervention and 5
Method of measurement
Perform culturing in the laboratory by a laboratory collaborator

Intervention groups

1

Description
Intervention group: On the first day of intubation, oral washing perform four times a day, with normal saline solution. On the second day of intubation, collect the initial sample of the pharyngeal and tracheal secretions and sent to the laboratory for culture, then with a 2% concentration of poly-myxin, nystatin and neomycin, prepared and combined by investigator administer with a syringe on the oral cavity and the lips are used in such a way that the mucus is impregnated with it. This action is repeated four times after normal oral saline mouthwash. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed.
Category
Prevention

2

Description
Control group: On the first day of intubation, mouth washing is perform four times in day, with normal saline solution. On the second day, first sampled the tracheal and pharyngeal discharge, then, daily after each oral wash with normal saline, a solution with the appearance and volume of the same basic solution used by the researcher with a syringe in the mouth and lips, is applied in such a way that the mucosa is impregnated. This action is repeated four times. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam-ol-Anbia Hospital in Zahedan
Full name of responsible person
Azizollah Jahantigh
Street address
No. 1, Shahid Motahari Blvd., Khatam Al Anbia Square.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshai
Street address
NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , University of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 6708
Email
public@zaums.ac.ir
Web page address
http://www.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Morteza Barani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Fax
Email
mimbaran@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Master of Science faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Fax
Email
aliakbar.keykha@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Morteza Barani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Fax
Email
mimbaran@yahoo.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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