Comparison the effect of comprehensive oral care program and combination of toothbrush and mouthwash with chlorhexidine 0.2% on the incidence of ventilator-associated pneumonia and oral health status in patients undergoing mechanical ventilation
Comparison of the effect of comprehensive oral care program and combined toothbrush and mouthwash program with 0.2% chlorhexidine on the incidence of ventilator-associated pneumonia and oral health status
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 90 patients, with permutation blocks were assigned to three groups
Settings and conduct
Intensive care unit of Khatam Al-Anbia Hospital in Zahedan.
The anesthesiologist interpreting the chest photograph will not know about the patients in the three groups, the person performing the oral health assessment know about the groups.
Participants/Inclusion and exclusion criteria
Hospitalized patients with mechanically ventilated endotracheal tube
Intervention groups
Comprehensive oral care program: wash hands and wear gloves, control endotracheal tube cuff pressure, raise the head of the bed by 30 to 45 degrees, brush the inner and outer surfaces of teeth, gums and tongue for 2 minutes using a baby toothbrush and Toothpaste with rotational movements, deep throat and mouth suction for 30 seconds while 0.9% normal saline is poured into the patient's mouth and teeth, mouthwash with 0.2% chlorhexidine antibacterial solution with a swab, moisturizing all mucosal surfaces The patient's mouth, gums and tongue are swabbed and vitamin A + D is used to lubricate the lips. Combined program of toothbrush and mouthwash with chlorhexidine 0.2%: The intervention is performed during 5 days of study for 5 minutes each time of oral care. With a baby toothbrush and antimicrobial toothpaste containing half a centimeter of fluoride, all the outer and inner surfaces of the teeth and gums are gently brushed with a circular motion. The teeth, tongue and palate surfaces are then brushed back and forth.
Main outcome variables
Ventilator-associated pneumonia,oral health status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201121049455N1
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Fatemeh Kordsalarzehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 0059
Email address
fa.salarzehi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-07, 1399/06/17
Expected recruitment end date
2021-09-08, 1400/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of comprehensive oral care program and combination of toothbrush and mouthwash with chlorhexidine 0.2% on the incidence of ventilator-associated pneumonia and oral health status in patients undergoing mechanical ventilation
Public title
Study of the effect of comprehensive oral care program and combination of toothbrush and mouthwash with chlorhexidine 0.2% on the incidence of ventilator-associated pneumonia and oral health status in patients undergoing mechanical ventilation.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 65-18 years
On the second day of the patient's hospitalization
Achieve a score less than or equal to 5 of the MCPIS criteria
No severe damage to face and mouth
No chronic disease and defective immune system
No movable dentures
The patient is not pregnant
Normal coagulation status
Exclusion criteria:
Performing a tracheostomy procedure during the study
Removal or replacement of endotracheal tube during the study
Detach from mechanical ventilation before 96 hours
Clearance from the ward
Allergy to chlorhexidine
Reluctance to continue the study by the legal guardian
Patient death
Evidence of signs and symptoms of aspiration after the start ofthe study according to the patient file
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using permutation blocks, patients were assigned to three groups: comprehensive oral care program, combined toothbrush and mouthwash program, and control. Considering that three groups were considered in the study, patients were divided into fifteen cases of six blocks, A group of comprehensive oral care program and B group of toothbrush and mouthwash and C control group (for example: (AABBCC, ABABCC, BBAACC,…). There were two people in each block from each group. The order of the blocks was determined randomly using a random number table and then the patients entered the comprehensive care, toothbrush, mouthwash and control group based on the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The ambiguity of the study was that the anesthesiologist interpreting the chest X-ray, which is part of the MCPIS instrument, did not know the patients in the three groups and confirmed the presence or absence of infiltration without knowing which group the patient was in. . Also, the person conducting the oral health assessment has no information about the patients' inclusion in the study groups.
Placebo
Not 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
Zahedan University of Medical Sciences,Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.ZAUMS.REC.1399.220
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
j15.6
ICD-10 code description
Pneumonia due to other Gram-negative bacteria
Primary outcomes
1
Description
Ventilator-dependent pneumonia score
Timepoint
Ventilator-dependent pneumonia score before intervention and end of fifth day
Method of measurement
Clinically modified pneumonia scale
2
Description
Oral health status
Timepoint
Beck oral assessment scale score during five days of study
Method of measurement
Beck Oral Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Comprehensive Oral Care Plan: The Comprehensive Oral Care Plan was designed based on previous studies and included performing the following 5 minutes of oral care each time: Washing hands and wearing gloves, controlling cuff tube pressure in Less than 25 mm Hg, raising the head of the bed by 30 to 45 degrees, brushing the inner and outer surfaces of the teeth, gums and tongue for 2 minutes using a baby toothbrush and toothpaste with rotating movements, deep throat and mouth suction. For 30 seconds while 0.9% normal saline is poured into the patient's mouth and on the teeth, rinse the mouth with 0.2% chlorhexidine antibacterial solution with a swab, moisten all surfaces of the patient's oral mucosa, gums and tongue using a swab. And use vitamin A + D to lubricate the lips. If there was an oral pharyngeal airway, it was removed, cleaned and repositioned in the patient's mouth.
Category
Prevention
2
Description
Intervention group: Combined program of toothbrush and mouthwash with chlorhexidine 0.2%: The intervention was performed during 5 days of study for 5 minutes each time of oral care. With a baby toothbrush and antimicrobial toothpaste containing half a centimeter of fluoride, all the outer and inner surfaces of the teeth and gums were gently brushed with rotating movements. The teeth, tongue surfaces, and palate were then brushed back and forth. After brushing, each part of the mouth was cleaned with sterile distilled water, so that the applicator was soaked with sterile distilled water and rinsed and cleaned with that mouth. The mouth, tongue, and teeth were then flushed with a swab soaked in chlorhexidine solution. The control group received routine oral care.
Category
Prevention
3
Description
Control group: Mouthwash with chlorhexidine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
Fariba Yaghobinia
Street address
Nursing & Midwifery school, Mashahir square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0059
Email
yaghoubinia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Square,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
Nmbakhsha@zdmv.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
Fariba Yaghobinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery school, Mashahir square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0059
Email
yaghoubinia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery school, Mashahir square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0059
Email
yaghoubinia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubinia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery school, Mashahir square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0059
Email
yaghoubinia@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