The prophylactic effect of cuminum cyminum extract on gastric residual volume in traumatic patients under ventilator hospitalized in intensive care unit.
This is a double-blind, randomized controlled trial with the aim of determining the effect of cumin extract on gastric residual volume in traumatic patients under ventilation in the intensive care unit. Inclusion criteria: traumatic patients with gastric ulcer and under ventilation; more than 24 to 48 hours of ICU admission; non-use of prokinetic drugs. Exclusion criteria: having a recent wound or surgery (10 days or less) on the digestive system; pregnant women; history of allergy to cumin products; intestinal paralysis; use of laxative drugs; abandoning from study and death. The research community includes traumatized patients undergoing mechanical ventilation in the ICU. Sample size consists of 60 patients who will be randomly assigned to randomly assigned random access intervention (cumin) control group (tap water) and the residual gastric volume of the patients will be measured before each intervention and every three hours after the intervention for 4 days.in the intervention group, 6 grams of the extract of cumin in 3 doses will be given to patients ,50 drops to 30 cc of tap water after gavage and patients in the control group daily 30 cc of tap water in 3 divided doses will be given. The residual volume will be measured in two groups every three hours after the intervention. Patients and assessors will not be aware of the type of drug they will receive in order to double-blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610297494N24
Registration date:2017-08-18, 1396/05/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-18, 1396/05/27
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences.
Expected recruitment start date
2017-09-21, 1396/06/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of cuminum cyminum extract on gastric residual volume in traumatic patients under ventilator hospitalized in intensive care unit.
Public title
The prophylactic effect of cuminum cyminum extract on gastric residual volume in traumatic patients under ventilator hospitalized in intensive care unit.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: traumatic patients with gastric and venous catheter; aged 18 to 75; passage of more than 24 to 48 hours of ICU admission; non-use of prokinetic drugs such as metoclopramide and erythromycin within 8 hours of intervention. Exclusion criteria: have a wound or recent surgery (10 days or less) on the stomach or gastrointestinal tract; Pregnant women; History of sensitivity to cumin herbs; history of hypothyroidism; history of hypoglycemia; skin sensitivities to cumin products due to The skin effects of the cumin on the body; the onset of intestinal paralysis; the use of laxative drugs; abandoning the study and death.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The residual volume is evaluated and recorded by the partner nurse every 3 hours after the intervention for 4 days (except at 3 and 6 o'clock in the morning). Gavage food is considered to be the same for all patients. In both groups the next gavage can be achieved by reaching the residual stomach volume to less than 500 cc. Patients and assessors will not be aware of the type of drug they will receive in order to double-blind. To increase the accuracy and reliability of the work in measuring the residual gastric volumes, six nursing colleagues who are shifting in three shifts are selected (two from each shifts) and the rate of return is recorded on ten patients, thus The reliability between the observers will be recorded by the researcher and then the correlation coefficient between these six will be examined.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Science
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
sari
Postal code
4816715793
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.MAZUMS.REC.96.10207
Health conditions studied
1
Description of health condition studied
Gastric residual volume
ICD-10 code
K31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Before each feeding, and every three hours after intervention for 4 days, through a gastric tube
Method of measurement
With using a 60 cc gavage syringe.
Secondary outcomes
empty
Intervention groups
1
Description
In the control group,30 cc of tap water every 8 hours will be gavaged (at 9:00,15:00,21:00) after food gavage for 4 days. The residual volume is measured before intervention and every 3 hours after intervention.
Category
Placebo
2
Description
The intervention group will receive cumin cyminum extract (Product of Barij Essen Co, Iran)
with a dose of 2 grams every 8 hours, so that 50 drops of cumin are deposited in 30 cc of tap water, then three times a day in (9, 15 and 21 oclock) after food gavage will be gavage by gavage syringe for 4 days and the residual volume will be measured before starting the gavage and every 3 hours after the start of intervention.