The aim of this study was to evaluate the effect of synbiotic on prevention of gastrointestinal intolerance in patients undergoing mechanical ventilation.
Design
In this study, patients undergoing mechanical ventilation and fed through the nasogastric tube were randomly assigned to experimental and control groups. Patients in the test group will receive a compound of synbiotics with code A and the control group will receive sugar powder with code B. Patients in both groups are fed twice daily for one week. Before the intervention and at the end of each day, the gastric residual volume, intra-abdominal pressure, frequency of defecation, gastrointestinal bleeding, and bowel sounds were measured by a nurse.
Settings and conduct
This study is performed in intensive care units in the hospitals affiliated to the Semnan University of Medical Sciences. Patients and who measure the gastrointestinal dysfunction symptoms are not aware of grouping patients in using the synbiotic.
Participants/Inclusion and exclusion criteria
Patients with age between 30 and 70 years, fed through the nasogastric tube and are connected to the mechanical ventilation for at least one week are included in the study. Patients undergoing gastrointestinal surgery, with malignancy, liver failure and multiple organ failure, body mass index greater than 35 and who take medications that affect on gastrointestinal motility are not included in the study.
Intervention groups
The experimental group receive compound of synbiotic (Lactocare) twice daily (9 am and 9 pm).
Control group receive sugar powder twice daily (9 am and 9 pm).
Main outcome variables
Gastric residual volume; Intra-abdominal pressure; times of defecation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006481N12
Registration date:2019-10-10, 1398/07/18
Registration timing:prospective
Last update:2019-10-10, 1398/07/18
Update count:0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of nutrition with synbiotic compounds on prevention of gastrointestinal dysfunction in patients undergoing mechanical ventilation
Public title
Effect of Synbiotic on gastrointestinal dysfunction in patients with mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Feeding through nasogastric tube.
Mechanical ventilation for at least one week.
Exclusion criteria:
Third degree burns
Gastrointestinal surgery
Multiple organ dysfunction
Post cardiac arrest
Body mass index more than 35
Liver failure
Use of drugs that affect gastrointestinal motility
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using stratified permuted block randomization. Patients are divided into two strata of addicted and non-addicted. For each stratum, a separate random assignment continues to reach the sample size. For random assignment in each stratum, four blocks of (A, B), which include different states of test and control sequences (AABB, ABAB …), are used. Block selection is done according to a random digits table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher puts the compounds of synbiotic and placebo in two containers marked with the letters A and B. The nurse, patient, and who perform evaluation outcome are unaware of the patient grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University Of Medical Sciences and Health Services
Street address
Semnan university of medical sciences, Shahid Akhlaghi intersection, Basij Blvd.,Semnan, Iran.