The effect of combined mouthwash on the prevention of ventilator-acquired pneumonia in mechanically ventilated patients admitted to intensive care unit
The effect of combined mouthwash on the prevention of ventilator-acquired pneumonia in mechanically ventilated patients admitted to intensive care unit
Design
Single-blind randomized clinical trial study
Settings and conduct
This Single-blind randomized clinical trial study will conduct in mechanically ventilated patients admitted to the intensive care unit.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients under mechanical ventilation; over 18 years old; Patients admitted to intensive care units.
Exclusion criteria: patients with brain death, patients with a GCS =3; mechanically ventilated patients less than 48 hours.
Intervention groups
Intervention group: patients in the intervention group will receive combination of gentamicin of 2%, colestin of 2% and vancomycin of 2% that it will be rubbed into the oral mucos for 4 times per day (every 6 hours).
Control group: patients in the control group will receive chlorhexidine mouthwash of 0.2% that it will be rubbed into the oral mucos for 4 times per day (every 6 hours).
Mouthwashes will be used until the creation of pneumonia symptoms, patient mortality, and endotracheal intubation in both groups.
Main outcome variables
microorganisms isolated from culture of endotracheal tube secretions; duration of mechanical ventilation; length of stay in intensive care unit and mortality in patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171221037983N5
Registration date:2019-09-30, 1398/07/08
Registration timing:retrospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Mohammad Amin Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
valizademohammadamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
2017-09-21, 1396/06/30
Scientific title
The effect of combined mouthwash on the prevention of ventilator-acquired pneumonia in mechanically ventilated patients admitted to intensive care unit
Public title
The effect of mouthwash on the prevention of ventilator-acquired pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mechanically ventilated patients
Age over 18 years
Admitted patients in the intensive care unit
Exclusion criteria:
brain death patients
Patients with GCS=3
Patients with mechanical ventilation less than 48 hours
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
124
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will randomly divided into two intervention and control groups. Individual numbers will be allocated to the intervention group and pair numbers to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be a single-blind study and patients will be blind that they belonged to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalat Street; Urmia University of Medical Sciences; Urmia; Iran
City
Urmia
Province
West Azarbaijan
Postal code
57147-83734
Approval date
2016-07-27, 1395/05/06
Ethics committee reference number
ir.umsu.rec.1395.205
Health conditions studied
1
Description of health condition studied
Mechanically ventilated patients
ICD-10 code
Y65.8
ICD-10 code description
Other specified misadventures during surgical and medical care
Primary outcomes
1
Description
microorganisms isolated from culture of endotracheal tube secretions
Timepoint
microorganism isolated from positive culture of endotracheal tube secretions from the onset of mouthwash till seven days after intervention or patient's death and discharge
Method of measurement
Culture of tracheal tube secretions
2
Description
Duration of mechanical ventilation
Timepoint
The length of mechanically ventilation during hospitalization at the intensive care unit.
Method of measurement
Days of Mechanical Ventilation
3
Description
mortality in patients
Timepoint
Patient's death during hospitalization at the intensive care unit
Method of measurement
Death or survival of the patient
Secondary outcomes
1
Description
Length of stay in hospital
Timepoint
The number of hospitalization days
Method of measurement
Number of days
Intervention groups
1
Description
Intervention group: combined mouthwash of gentamycin of 2%, Clestine of 2% and vancomycin of 2% that it will rubbed for 4 times per day (every 6 hours) into patients' oral mucosa with a finger.
Category
Treatment - Other
2
Description
Control group: Chlorhexidine mouthwash of 0.2% that it will rubbed for 4 times per day (every 6 hours) into patients' oral mucosa with a finger.