The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units of Poursina teaching remedial hospital of Rasht
The aim of this study was to investigate the effect of probiotic capsule consumption on the incidence of Ventilator-Associated Pneumonia in patients under mechanical ventilation admitted to intensive care units.
Design
The present study is a clinical trial study with a control group, triple blinds, parallel, phase 3 with a sample size of 92 people. Block randomization based on block permutation is used for randomization. To hide the allocation, block sizes are also randomly selected (4, 6). Https://www.sealedenvelope.com/ was used to generate a random allocation sequence.
Settings and conduct
The study sample is selected by available sampling method from mechanically ventilated patients admitted to the intensive care units of Poursina Hospital. The subjects, evaluators and analysts do not know the type of capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: written informed consent from the client's family or guardian; age 18 years and older; under mechanical ventilation for more than 48 hours and more than 48 hours have passed since the intubation.
Exclusion criteria: pregnancy at the time of admission; multiple organ dysfunction; pneumonia; chronic pulmonary disease; immunosuppressive diseases; immunosuppressive drug usage; stomach, esophagus and intestines damage and airway injury.
Intervention groups
Patients are divided into two groups: probiotics and placebo. Patients in the probiotic group receive Lactocare capsules (manufactured by Zist-Takhmir pharmaceutical company) and patients in the control group receive placebo capsules made by Zist-Takhmir companies. All patients receive routine nursing care prevention of Ventilator-Associated Pneumonia.
Main outcome variables
Incidence of Ventilator-Associated Pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001174N13
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-10, 1400/01/21
Expected recruitment end date
2021-10-13, 1400/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units of Poursina teaching remedial hospital of Rasht
Public title
The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent from the client's family or guardian
Age 18 years and older
Under mechanical ventilation for more than 48 hours
Not more than 48 hours have passed since the intubated
Exclusion criteria:
Pregnancy at the time of admission
Multiple organ dysfunction
History of Pneumonia
Having chronic pulmonary disease
Having immunosuppression diseases
Immunosuppressive drug usage
Stomach, esophagus and intestines damage
Airway injury
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on block permutation is used for randomization. To hide the allocation, block sizes are also randomly selected (4, 6). If the patient leaves the study, the relevant patient code will be assigned to the new sample. The site https://www.sealedenvelope.com/, which was set up to randomize clinical trials, will be used to generate a random allocation sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Study subjects are blind to the study intervention due to lack of knowledge about the type of drug (gavage as well as placebo or main drug). In the blinding of the evaluators, the ICU physician will not know about the randomization and the patient group to check the chest image and the final diagnosis of VAP, nor will the coordinator and data collector (student) know about the patient group. The project supervisor is responsible for blinding other researchers and they will have access to all the information. The student and Statistics specialist, who is in charge of the final analysis of the project, are not aware of the type of intervention of the defined groups (probiotics or placebo) in SPSS software. The sample allocator to the groups is the student implementing the project. Due to the use of placebo in the project, the student who conducting the project will not be aware of the type of intervention performed in the groups. To hide the allocation, the size of the blocks is randomly selected (4, 6).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Guilan University Of Medical Science
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences., In front of 17Sharivar Hospital., Shahid Siadati St., Namjoo Blvd.
City
Rasht
Province
Guilan
Postal code
4146939114
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.GUMS.REC.1399.552
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders
Primary outcomes
1
Description
The incidence of Ventilator-Associated Pneumonia
Timepoint
All patients in both probiotic and placebo groups are monitored daily. Patients are monitored for Ventilator-Associated Pneumonia for up to 14 days after intubation and initiation of probiotic or placebo.
Method of measurement
The American College of Chest Physicians and ICD-10 criteria will be used to diagnose Ventilator-Associated Pneumonia in intubated patients admitted to intensive care units. These criteria; "Existence of new and continuous infiltration in the chest image with 2 or 3 cases: increase in temperature above 38.5 ° C or decrease in temperature below 35 ° C, increase in white blood cells above 12,000 per microliter, or a decrease in white blood cells to less than 3,000 per microliter, and purulent sputum are considered to indicate Ventilator-Associated Pneumonia. For microbiological diagnosis of ventilator-associated pneumonia, " Endotracheal Aspirate" culture will be used in a "quantitative" manner. In this method, a number of colonies above 100,000 is considered as a microbiological diagnosis of ventilator-dependent pneumonia.
Secondary outcomes
1
Description
Duration of mechanical ventilation
Timepoint
It is checked daily by the researcher.
Method of measurement
Researcher-made data collection form.
2
Description
Duration of hospitalization in the Intensive Care Unit
Timepoint
It is checked daily by the researcher.
Method of measurement
Researcher-made data collection form.
3
Description
Mortality rate
Timepoint
It is checked daily by the researcher.
Method of measurement
Researcher-made data collection form.
Intervention groups
1
Description
Intervention group: The subjects in the probiotic group receive Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) along with routine nursing care to prevent VAP. Each capsule Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) contains ten to the power nine clones probiotic bacteria consisting of Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus plantarum, Lactobacillus Gsry, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium Breve, Bifidobacterium longum and Streptococcus thermophilus along with fructooligosaccharide (FOS) are used as prebiotics. The above capsule is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive a placebo capsule made by Zist-Takhmir Company along with routine VAP nursing care. The placebo capsule (manufactured by Zist-Takhmir Pharmaceutical Company) contains starch, which is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Educational & Remedial Center, Rasht
Full name of responsible person
Atefeh Ghanbari
Street address
Poursina Educational & Remedial Center., Namjoo St