Comparison the effect of open and closed endotracheal suction systems on the results of the smear and bacterial culture in patients under mechanical ventilation in intensive care unit
Comparison the effect of open and closed endotracheal suction systems on the results of the smear and bacterial culture in patients under mechanical ventilation
Design
A single-blind, randomized controlled clinical trial with parallel groups, with 52 patients (28 patients in open suction group and 28 patients in closed suction group) and evaluation of study outcomes after 72 h with smear and tracheal cultures in patients admitted to ICU ward of Valiasr Hospital in Birjand city
Settings and conduct
After final approval of the research topic by the Graduate Council and Regional Ethics Committee of Gonabad University of Medical Sciences and coordination with the research environment, informed consent was obtained from the caregiver and, if consent, at the beginning of the patient's admission to the ICU, a sample tracheal culture was obtained and sent to the central laboratory of Valiasr Hospital. Patients with negative primary cultures of endotracheal secretions were then selected and randomly assigned into two groups of open or closed suction and received the relevant intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have at least three days in the ICU, Being under mechanical ventilation, Lack of respiratory infections or sepsis, primary tracheal culture sample is negative, Not more than 6 hours after the patient's intubation, Accept ICU admission less than 24 hours after hospitalization; Exclusion criteria: Patient death, Use of immunosuppressive and antibiotic drugs use during the study period, Cardiopulmonary resuscitation, Extubation earlier than the expected
Intervention groups
Experimental group: receiving closed suction system; Control group: receiving open suction system
Main outcome variables
The results of the smear and bacterial culture in patients under mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191014045110N1
Registration date:2019-10-28, 1398/08/06
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Fatemeh Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 7082
Email address
frezaee2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2019-09-06, 1398/06/15
Trial completion date
2019-10-07, 1398/07/15
Scientific title
Comparison the effect of open and closed endotracheal suction systems on the results of the smear and bacterial culture in patients under mechanical ventilation in intensive care unit
Public title
the effect of two methods endotracheal suction systems on the results of the smear and bacterial culture in patients under mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least three days stay in the ICU.
Under mechanical ventilation (intubation or tracheostomy).
Patient's primary endotracheal culture should be negative.
Not more than 6 hours after the patient's intubation.
Accept ICU admission less than 24 hours after hospital admission.
Not have acute or chronic respiratory infections and sepsis.
Exclusion criteria:
Patient death
Cardiopulmonary resuscitation
Extubation earlier than expected
Use of immunosuppressive drugs and start of antibiotic use during the study period
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
56
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Purpose-based sampling was performed among all patients admitted to the intensive care unit of Valiasr Hospital in Birjand, and if the inclusion criteria were met. In the second stage, patients were randomly assigned to either open or closed suction group. Patients whose right file number was even were assigned to the open suction group and patients with right file number was odd were assigned to the closed suction group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Samples of endotracheal secretion culture sent to the laboratory were examined by a researcher who was one of experienced laboratory personnel and blind to division of study groups into open and closed suction groups. In addition, data analysis and outcome evaluation done by someone other than the main researchers of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad university of Medical Sciences, Near Asian Road., Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.GMU.1397.113
Health conditions studied
1
Description of health condition studied
Patients under mechanical ventilation in intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The results of the smear and bacterial culture in patients under mechanical ventilation
Timepoint
Before and 72 hours after intervention
Method of measurement
Microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the closed suction system, without weaning from the ventilator and after the patient was hyperoxygenated with 100% oxygen by the ventilator and through the catheter that is placed between the endotracheal tube and ventilator Y-like device, suctioning was done.This procedure was done in various shifts by nurses who had received theoretical and practical training in the principles of suctioning.
Category
Prevention
2
Description
Control group: For suctioning in the open system group, after hyperoxygenated the patient with 100% oxygen for 1 minute by the ventilator and aseptic conditions (sterile gloves and sterile suction catheter) and removing the patient from the ventilator, suctioning was done. The suction catheter in this procedure was replaced after each use.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital affiliated with Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Rezaee
Street address
Valiasr Hospital., Razi Ave., Ghaffari Blvd., Birjand City
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3244 3000
Email
Frezaee2000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences., Near Asian Road., Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Rezaee
Position
Master Student in Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences.,Near Asian Road., Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Frezaee2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Moosa Sajjadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences., Near Asian Road., Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
sajjadi1975@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Rezaee
Position
Master Student in Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Hospital., Razi Ave., Ghaffari Blvd., Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3244 3000
Email
Frezaee2000@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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available