Protocol summary

Study aim
Determining and comparing the incidence of late-onset pneumonia in the two studied groups
Design
Patients will be divided into groups by block randomization method (block size 4). Randomization is performed by an epidemiologist or using the online program at sealedevelope.com. Due to the double-blind nature of the study, the data collector and the data analyst do not know about our grouping, but the anesthesiologist who is on the patient's bed during surgery knows about the grouping
Settings and conduct
The intervention is performed in the ICU of Valiasr Hospital. In this study, the patients, as well as the project data analyst and the intern who is responsible for completing the questionnaires, will be unaware of the division of patients into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients requiring mechanical ventilation Age 18 to 65 years؛ Absence of lung disease and lung mass؛ No use of chemotherapy drugs؛ Absence of enteral nutrition؛ Failure to receive antibiotics prior to onset of VAP Exclusion criteria Patients who require mechanical ventilation for less than 48 hours (because they are at low risk of VAP)؛ death؛ Lack of consent to participate in the study by the guardian Reintubation
Intervention groups
Intervention group: In one group, the cuff pressure is considered to be at least normal and its amount will be 20 to 22 cm of water. In order to check the cuff pressure, it will be measured by a manometer every 4 hours. Intervention group: cuff pressure will be considered as maximum normal and its amount will be 30 to 32 cm of water. In order to check the cuff pressure, it will be measured by a manometer every 4 hours.
Main outcome variables
Duration of mechanical ventilation and mortality and incidence of pneumonia with early onset and late onset in patients will be recorded. The severity of the disease will be recorded daily for three days.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230730058978N1
Registration date: 2023-10-08, 1402/07/16
Registration timing: registered_while_recruiting

Last update: 2023-10-08, 1402/07/16
Update count: 0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Milad Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3722 9462
Email address
miladlytod@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-27, 1402/07/05
Expected recruitment end date
2023-10-17, 1402/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endotracheal tube cuff pressure (minimum/maximum) in the prevention of ventilator-induced pneumonia in patients admitted to ICU
Public title
The effect of endotracheal tube cuff pressure (minimum/maximum) in the prevention of ventilator-induced pneumonia in patients admitted to ICU
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need of mechanical ventilation, age 18 to 65 years absence of lung disease and lung mass absence of chemotherapy drugs absence of enteral nutrition absence of antibiotics before the start of VAP
Exclusion criteria:
Patients who require mechanical ventilation for less than 48 hours (because they are at low risk of VAP). Lack of consent to participate in the study by the guardian Reintubation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 134
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into 2 groups by block randomization method (block size 4). Case sequencing is performed by an epidemiologist using an online program at www.sealedevelope.com. Hiding the random chain is done by the method of opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blind nature of the study, the patients and the data collector and the data analyst do not know about the groupings, but the anesthesiologist who is at the patient's bedside during surgery and knows about the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak Medical University
Street address
Sardasht - arak medical university
City
arak
Province
Markazi
Postal code
3848176941
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.ARAKMU.REC.1401.279

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
ventilator-associated pneumonia
Timepoint
During the intervention and 4 days after the intervention
Method of measurement
Cuff Pressure Measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In a group, cuff pressure is considered as minimum normal and its amount will be 20 to 22 cm of water .
Category
Treatment - Devices

2

Description
Intervention group: and another group The cuff pressure will be considered as maximum normal and its amount will be 30 to 32 cm of water.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
valiaasr hospital
Full name of responsible person
Milad Ghaffari
Street address
Valiaasr squar., Valiaasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2204
Fax
+98 86 3223 1283
Email
pr_valieasr@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/valiasrhos/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
davood hekmatpou
Street address
sardasht - arak medical university
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Fax
+98 86 3417 3526
Email
miladlytod@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
valiaasr hospital
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
Arak University of Medical Sciences
Full name of responsible person
behnam mahmudie
Position
Associate Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
valiaasr squar - valiaasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
0098 86222202
Email
b.mahmudie@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
behnam mahmudie
Position
Associate Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
valiaasr squar - valiaasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
0098 86 222202
Email
b.mahmudie@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
behnam mahmudie
Position
Associate Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
valiaasr squar - valiaasr hospital
City
arak
Province
Markazi
Postal code
3814957558
Phone
0098 86 222202
Email
b.mahmudie@arakmu.ac.ir

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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