Comparison of the effect of apple extract and oral drops gastrolit (Zataria multiflora) on gastric residual volume and pulmonary aspiration in patients under mechanical ventilation in the Intensive Care Unit of Valiasr hospital of Zanjan in 2020
Comparison of the effect of apple extract and oral drops gastrolit(Zataria multiflora)on gastric residual volume and Pulmonary aspiration in patients under mechanical ventilation in the Intensive Care Unit of Valiasr hospital of Zanjan in 2019
Design
Patients will be randomly divided into 3 groups using blocking method.
Settings and conduct
The present study will be a single blind randomized clinical trial on patients 18-65 years old with mechanical ventilation requiring gastrointestinal nutrition through gastric catheter admitted in Vali-e-Asr Hospital of Zanjan who have inclusion criteria.
Blindness will be such that the study population will not know which group was randomly assigned to one of the three groups.
Participants/Inclusion and exclusion criteria
Patient under mechanical ventilation
Hemodynamic stability
No history of aspiration when entering the study
Absence of electrolyte disorders affecting gastrointestinal motions such as hypokalemia, hyperglycemia
Feeding the nasal-gastric tube or the oral-gastric tube
Intervention groups
The control group will be gavaged after 9 Am, 3 pm and 9 pm with 20 cc of water.
In a group gavaged of 8 cc apple extract with 12 cc water immediately after the main meal at 9 am, 3 pm and 9 pm for 5 days The second group will be gavaged with 20 drops of Gastrolith (Thyme essential oil) plus 20 cc water 3 times daily before the main meals at 9 am, 3 pm and 9 pm for 5 days.
In each of the three groups, the remaining gastric volume will be measured and recorded before each gavage during the study.
Main outcome variables
Gastric residual volume-
Pulmonary aspiration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160818029414N7
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Vahideh Rashtchi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 341 1683
Email address
rashtchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of apple extract and oral drops gastrolit (Zataria multiflora) on gastric residual volume and pulmonary aspiration in patients under mechanical ventilation in the Intensive Care Unit of Valiasr hospital of Zanjan in 2020
Public title
Comparison of the effect of apple extract and oral drops gastrolit (Zataria multiflora) on gastric residual volume and pulmonary aspiration in patients under mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient under mechanical ventilation
Hemodynamic stability
No history of aspiration when entering the study
Absence of electrolyte disorders affecting gastrointestinal motions such as hypokalemia, hyperglycemia
Feeding the nasal-gastric tube or the oral-gastric tube
Exclusion criteria:
Having diabetes, pancreatitis, gastrectomy
Gastrointestinal bleeding and peptic ulcer
Nutrition intolerance
Gastrointestinal drugs such as metoclopramide, ondansetron, cisapride and erythromycin
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly assigned using blocking method.
Blinding (investigator's opinion)
Single blinded
Blinding description
After randomization, we do not tell the patient in which of the three groups.
In fact, the interventionist and the analyst are aware of the allocation of groups, but patients do not know in which group they are.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan-Azadi Boulevard - First Republic Street - Front of Asian Insurance - Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.ZUMS.REC.1398.428
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Every three hours except 3 in the morning
Method of measurement
Lavender contents of the stomach with a syringe of 60 cc
Secondary outcomes
1
Description
Pulmonary aspiration
Timepoint
On admission to ICU, day 3 and day 5 of the study
Method of measurement
Using a glucose oxidase kit and a ph gauge tape
Intervention groups
1
Description
Intervention group: In the first group will gavage at 9 am, 3 pm and 9 pm, 8 cc apple extract 12 cc water immediately after gavage main meal.
Category
Prevention
2
Description
Intervention group: The second group will gavage 20 drops of Gastrolith (Zataria multiflora) plus 20 cc water 3 times daily before the main meals at 9 am, 3 pm and 9 pm for 5 days.
Category
Prevention
3
Description
Control group: The control group will be gavaged after 9 am and 3 pm and 9 pm with gavage meals.