The Effects of Open and Closed Suction Methods on Occurrence of Ventilator Associated Pneumonia in patient who admitted in intensive care unit at sina hospital
comparing the open suctioning system versus closed suctioning system on occurrence of ventilator-dependent pneumonia in the ICU of Sinai hospital
Design
Randomized clinical trial with parallel control group, 40 patients enrolled between July 2019 and July 2020 with blinded outcome assessment using rand function in Microsoft Excel software
Settings and conduct
This project will be conducted in the intensive care unit at Sina hospital.
Patients will be divided into two groups randomly. In the Open suction group, suction will be performed using a single-use catheter as the routine of the wards for a maximum of 15 seconds. In the closed suction group, suction will be performed and the suction catheter will be replaced every 48 hours. In both groups, prophylaxis standards against VAP will be followed. The following data will be collected for all patients: Gender, age, number of the days being under ventilator. VAP diagnosis will be made based on having CIPS criteria (CLINICALLY INFECTION PULMONARY SCORE) while being under mechanical ventilation for 48 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are admitted to the intensive care unit at Sina hospital in 2019-2020; age>18 years; need of mechanical ventilation for at least 72 hours. Exclusion criteria: no satisfaction of patients family, patients who have pneumonia before the study
Intervention groups
Closed Suction: suction will be performed with closed system every one hour during ICU stay.
open suction: suction will be performed by single-use routine catheters every one hour during ICU stay. The duration of suction will be less than 15 seconds.
Main outcome variables
Ventilator-associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100112003051N12
Registration date:2020-07-25, 1399/05/04
Registration timing:retrospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-15, 1398/04/24
Expected recruitment end date
2020-07-14, 1399/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Open and Closed Suction Methods on Occurrence of Ventilator Associated Pneumonia in patient who admitted in intensive care unit at sina hospital
Public title
The Effects of Open and Closed Suction Methods on Occurrence of Ventilator Associated Pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who are intubated for more than three days
Patients who are admitted in intensive care unit at Sina hospital
Exclusion criteria:
Patient who had pneumonia before study
Patient who extubated in less than three days
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by using simple random allocation method (Random number table). Numbers extracted from tables that are odd are assigned to intervention group 1 and even numbers are assigned to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Open and closed suction are performed by the nurse who not involved in the study, and the data is recorded by the researcher's colleague who is one personnel of ICU and, hence, the researcher is not aware of the recorded data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science
Street address
Tehran university of medical science, Poursina Ave.,16th Azar street.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.414
Health conditions studied
1
Description of health condition studied
Ventilated associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Incidence of ventilation associated pneumonia
Timepoint
Before intervention day1 day 2 day 3
Method of measurement
CIPS criteria (CLINICALLY INFECTION PULMONARY SCORE)The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment ، tracheal suction and white blood cell count )
Secondary outcomes
1
Description
Pulse rate
Timepoint
Before and after suctioning
Method of measurement
Using non-invasive cardiac monitoring
2
Description
Respiratory rate
Timepoint
Before and after suctioning
Method of measurement
Using non invasive cardiac monitoring
3
Description
Arterial saturation of oxygen
Timepoint
Before and after suctioning
Method of measurement
Using pulse oximeter
4
Description
Temperature
Timepoint
Daily after suctioning
Method of measurement
Using tympanic thermometer
Intervention groups
1
Description
Intervention group (Closed Suction): suction will be performed with closed system every one hour during ICU stay.
Category
Treatment - Devices
2
Description
Control group(open suction): suction will be performed by single use routine catheters every one hour during ICU stay. Duration of suction will be less than 15 seconds.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Ali Atlasbaf
Street address
Sina hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
bami3h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atabak Najafi
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 4208
Email
bami3h@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Atlasbaf
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 5. Andishmand Ave., Mollasadra Blvd.
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3365 6495
Email
bami3h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atbak Najafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Imam Khomeini Street.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
bami3h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Atlasbaf
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 5, Andishman Ave., Mollasadra Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3365 6495
Email
bami3h@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The data from the study will be published as an article.
When the data will become available and for how long
6 to 12 months
To whom data/document is available
Everyone in the field of medicine and nursing
Under which criteria data/document could be used
People who study the effects of suction type.
From where data/document is obtainable
Email to the person in charge of the project
What processes are involved for a request to access data/document
Email to Applicant - Request from University Research Assistant - If the information is positive to Providing information to the applicant