Evaluation of the effects of probiotics on the prevalence of ventilator-associated pneumonia in patients with multiple trauma admitted to the intensive care unit of brain surgery
Evaluation of the effects of probiotics on the prevalence of ventilator-associated pneumonia in patients with multiple trauma admitted to the intensive care unit of brain surgery
Design
This randomized clinical trial (quadruple blocks) was performed with the control group, not blinded and in parallel groups with the participation of 150 patients admitted to the intensive care unit.
Settings and conduct
This randomized trial study was performed with the participation of 150 patients admitted to the intensive care unit of Imam Reza Hospital in Tabriz. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: required mechanical ventilation and exclusion criteria included death during the intervention and history of lung disease.
Intervention groups
Participants were divided into two groups. The intervention group received one probiotic capsule every twelve hours by gavage and the control group received one placebo capsule every twelve hours by gavage.
Main outcome variables
Ventilator-associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N18
Registration date:2020-10-30, 1399/08/09
Registration timing:prospective
Last update:2020-10-30, 1399/08/09
Update count:0
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of probiotics on the prevalence of ventilator-associated pneumonia in patients with multiple trauma admitted to the intensive care unit of brain surgery
Public title
Effects of probiotics on the prevalence of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Requires mechanical ventilation
Exclusion criteria:
Death during intervention
History of lung disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
By randomization method, 4 permutation blocks were assigned to one of the two intervention and placebo groups; Thus, first 6 possible modes of 4 blocks (BAAB, ABBA, BABA, AABB, ABAB, BBAA) were listed and a number from 1 to 0 was assigned to each block. Then, a number between 1 and 0 was randomly selected and the subjects were assigned to the intervention group (A) and placebo (B) based on the relevant block and the selected number. This was continued until the sample size was completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2018-09-10, 1397/06/19
Ethics committee reference number
IR.TBZMED.REC.1397.499
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
Every 12 hours for three days
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the beginning of the study, the patients received two daily Lactocare capsules (Bio-Fermentation Pharmaceutical Company-Tehran-Iran) with 20cc of distilled water through NG tube once every twelve hours (9 o’clock in the morning and evening - at least two hours after the last NG tube)
Category
Prevention
2
Description
Control group: In the control group, a starch capsule was used as a placebo, which was given to the patient by gavage (twice daily - once every twelve forearms - at 9 am - at least two hours after the last gavage).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Azadi Ave, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
30
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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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