Determination of Oral Drop Mentha spicata (Supermint) effect on Gastric Residual Volume in Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit
Design
A randomized, triple blinded, controlled trial with parallel groups
Settings and conduct
The study is a randomized, triple blinded, parallel-group controlled trial that is performed at Bohlul Hospital in Gonabad, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients under mechanical ventilation with >24 hours stay in the intensive care unit (ICU), ages between 18 to 65 years old, informed consent of parents or legal guardian
Non-inclusion criteria: Having gallstones, history of active gastrointestinal bleeding, malignancies, gastrointestinal ulcer, diabetes and pancreatitis, Pregnancy and breastfeeding, history of Hypothyroidism according to the statement of people accompanying the patient, Oral nutrition or use of a duodenal catheter
Intervention groups
Patients in the intervention group receive 20 drops of the Supermint solution along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding. The control group patients receive 20 drops of placebo along with 40 ml of water.
Main outcome variables
Gastric residual volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045868N1
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Fatemeh Mohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5213
Email address
f.mo6325@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
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
Effect of Oral Drop Mentha spicata (Supermint) on Gastric Residual Volume in Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit
Public title
Effect of Oral Drop Mentha spicata (Supermint) on Gastric Residual Volume in Mechanically Ventilated Patients Hospitalized in the Intensive Care Unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients under mechanical ventilation with >24 hours stay in the intensive care unit (ICU)
Ages between 18 to 65 years old
Informed consent of parents or legal guardian
Exclusion criteria:
Having gallstones
History of active gastrointestinal bleeding, malignancies, gastrointestinal ulcer, diabetes and pancreatitis
Pregnancy and breastfeeding
History of Hypothyroidism according to the statement of people accompanying the patient
Oral nutrition or use of a duodenal catheter
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Permuted block randomization with a fixed block size of 4
Unit of randomization: Individual
Tools used in randomization: sealed envelops, computer software
How the random sequence is built: Random allocation software
How allocation concealment is carried out: Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients in both groups are unaware of the treatment being used. The intervention and the assessment of the result are performed by two different individuals, and so the result assessor will not be informed of the form of treatment being allocated. For the gavage material, A and B codes are considered, and the data analyzer is not told the type of gavage material.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.GMU.REC.1398.187
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 gavage during the study
Method of measurement
By aspirating the stomach contents with a 60 ml syringe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive 20 drops of the Supermint solution along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding.
Category
Prevention
2
Description
Control group: Patients in the control group receive 20 drops of the plasebo along with 40 ml of water, 3 times daily for 4 days, from the first day of their feeding.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bohlul Hospital in Gonabad
Full name of responsible person
Ali Delshad Noghabi
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
ali_delshad2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mmakhosravan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
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
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad Noghabi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
ali_delshad2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad Noghabi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
ali_delshad2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Delshad Noghabi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Road Border
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
ali_delshad2000@yahoo.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