1. Provide a scientific, low-cost, easy and practical solution for the placement of gastric nasal tubes in patients with reduced level of consciousness
2. Provide an effective way to reduce the incidence of gastrointestinal obstruction in patients with reduced level of consciousness
3. Provide an effective way to optimize the time spent by nurses to place gastric nasal tubes in these patients
Design
Clinical trial with control group, one-way blind, randomizedIntervention on 170 adolescent patients with loss of consciousness (Myarglaskv8-3)
Settings and conduct
The research environment in this study includes all sections of Ganjavian Hospital in Dezful Which will have patients with low levels of consciousness.
A total of 170 samples with study entry criteria were selected They will then be randomly assigned to two intervention and control groups.How to assign patients to each study group by block random methodAnd will be done using 6 blocks.
Participants/Inclusion and exclusion criteria
1. Age 75-18 years
2. Doctor's prescription for feeding through the gastric nasal tube
3. Having stable vital signs (blood pressure: 8/89/139/120 / pulse rate: 100-60 times per minute body temperature: 37.6-36 Breathing number: 20-12 times per minute)
4. Inability to take medicine or food through the mouth
5. Lack of hematological diseases or use of anticoagulants
6. Absence of severe jaw trauma and face
Intervention groups
Determining the effect of lying position on the side on the success rate of gastric nasal catheter insertion in patients with low level of consciousness
Main outcome variables
1. Placement of gastric nasal tube with lateral position in patients with reduced level of consciousness Increases the success rate of placement of gastric nasal tubes
2. Placement of gastric nasal tube with lateral position in patients with reduced level of consciousness Increases Reduces the complications of piping.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200601047631N1
Registration date:2020-07-18, 1399/04/28
Registration timing:registered_while_recruiting
Last update:2020-07-18, 1399/04/28
Update count:0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Elham Merdasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4229 8213
Email address
elham.merdasi68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lateral positioning on success of nasogastric tube insertion in unconscious patients
Public title
The effect of lateral positioning on success of nasogastric tube insertion in unconscious patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Doctor's prescription for feeding through the gastric nasal tube
Inability to take medicine or food through the mouth
Lack of hematological diseases or use of anticoagulants
Low level of consciousness (Glasgow standard between 3-8)
Exclusion criteria:
Existence of severe jaw trauma and face
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
170 patients with reduced level of consciousness using block random method and It will be done using 6 blocks.Patients are divided into two groups: intervention and control.The placement of these patients is random and in each block the order of patients is completely different.
Blinding (investigator's opinion)
Single blinded
Blinding description
The placement of random patients in each block is completely different.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciencesl
Street address
Department of Research Development and Technology, Ahvaz University of Medical Sciences, Street March, Shahr danshgahy, Golestan Ave, Ahvazn
City
Ahvaz
Province
Khouzestan
Postal code
6135-15794
Approval date
2019-10-23, 1398/08/01
Ethics committee reference number
IR.AJUMS.REC.1398.521
Health conditions studied
1
Description of health condition studied
Includes all patients with decreased level of consciousness.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
level of consciousness
Timepoint
Glasgow criteria 3-8
Method of measurement
Glasgow criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group of patients during nasogastricTub placed in the lateral position.Checklist information is entered.This information includes: time, number of attempts, complications (cough, bleeding, gag reflex), gastric nasal catheter insertion, age, sex, weight, height.
Category
N/A
2
Description
Control group:In this group of patients during nasogastricTub placed in the Supine position.Checklist information is entered.This information includes: time, number of attempts, complications (cough, bleeding, gag reflex), gastric nasal catheter insertion, age, sex, weight, height.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ganjavian hospital
Full name of responsible person
Simin Jahani
Street address
No.90., Jamistreet., Emam Khomeini Ave., Dezful
City
Dezful
Province
Khouzestan
Postal code
6455165431
Phone
+98 61 4229 8137
Email
elham.merdasi68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
SiminJahani
Street address
No.90., Jamistreet., Emam Khomeini Ave., Dezful
City
Ahvaz
Province
Khouzestan
Postal code
6455165431
Phone
+98 61 4229 8137
Email
jahanisimin50@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
50
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
Ahvaz University of Medical Sciences
Full name of responsible person
SiminJahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Ahvaz Jundishapur University of Medical Sciences., Esfand St., University City., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 319 8223
Email
jahanisimin50@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Ahvaz Jundishapur University of Medical Sciences., Esfand St., University City., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009891663198223
Email
jahanisimin50@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Mardasi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.90., Jami street., Emam Khomeini Ave., Dezful
City
Dezful
Province
Khouzestan
Postal code
6455165431
Phone
+98 61 4229 8137
Email
elham.merdasi68@gmail.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