Increase the success rate of the Naso Gastric tube insertion
Design
Two arm parallel group randomised trial and outcome assessment in 130 patients
Settings and conduct
This study was carried out at Sina Hospital affiliated to the University of Tehran in anesthetized patients who have an endotracheal tube and are needed to the NG tube.
Participants/Inclusion and exclusion criteria
incusion criteria ,All patients with an endotracheal tube and for any reason need an NG tube
Any obstruction in nostril, nasopharynx and coaglopathy was excluded
Intervention groups
All patients have anesthetized and reduced consciousness that have an endotracheal tube and need nNG tube. They are divided into two groups of intervention and control. In intervention group after lubrication the intrance of NG tube a bowden wire inserted into the tube until the end then the nostril was lubricated with jel passing the NG tube through the nose and reching to the hypopharynx some one do the jow trust and we try to pass the NG through the esophagous untill first line on NG rech to the nostril,at this time another person began to withdrow bowden wire and We will continue to insert the tube to the required location
In the control group, these steps are carried out without putting Bowden wire
Main outcome variables
The time spent on putting NG
Number of attempts to place NG
The occurrence of any complications during the delivery of NG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N4
Registration date:2020-06-23, 1399/04/03
Registration timing:retrospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-09-24, 1398/07/02
Actual recruitment start date
2019-02-09, 1397/11/20
Actual recruitment end date
2020-02-09, 1398/11/20
Trial completion date
2020-02-24, 1398/12/05
Scientific title
Placing a Naso Gastric Tube (NGT) with a Rope wire guid in Unconscious patients with an endotracheal tube
Public title
NG tube insetion with guide wire
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All intubated patients that need NG tube
Exclusion criteria:
Any deformity in nostril and obstruction in nasopharynx
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients with inclusion criteria
Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group.
The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of school of medicine tehran university of medical sciecences
Street address
sina hospital-hasan abad sq-emam khomeni st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.456
Health conditions studied
1
Description of health condition studied
Gastrointestinal diseases
ICD-10 code
K31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
Number of times and time spent on NG placement
Timepoint
At the same time that we carry out the procedure
Method of measurement
The length of time that NG passes through the nose tip to reach the stomach
Secondary outcomes
1
Description
Number of failures
Timepoint
During insertion of NG tube
Method of measurement
If the NG tube does not enter the stomach and we do not hear the sound of air passing through the stomach
2
Description
Complications such as bleeding or insertion of tube to trachea
Timepoint
During insertion of NG tube
Method of measurement
Existence of blood in the throat or nose and hearing breathing sounds from the NG tube
Intervention groups
1
Description
Intervention group: The placement of a NG tube in patients with an endotracheal tube is examined by a special guide called rope wire, which is inserted into the NG tube and the speed of passage from nose, nasopharynxand esophagus Will be evaluated. The speed of NG placement without guide wire Will be evaluated
Category
Treatment - Devices
2
Description
Control group: The gastric tube is passed through the nose without a guide wire, and after the tube reaches the throat, the mandible is pulled up to facilitate insertion of the tube to esophagus then the time of passage of the tube and placement in the stomach and the success rate of this method in correct placement of the tube in the stomach will be evaluated
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza khajavi
Street address
Sina Hospital Hassan Abad sq, Emmam Khomini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Keshavarz Blvd., Ghods St., Central Organization of the University, Sixth Department of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Hassan Abad sq, Emmem Khomini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital ,Hassan abad sq, Emmam Khomine st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sharareh Jahangiri
Position
Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Hassan Abad sq Emmem Khomini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 63128
Email
shararehjahangiri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the main study data
When the data will become available and for how long
6 month
To whom data/document is available
University and industry researchers
Under which criteria data/document could be used
Share experiences
From where data/document is obtainable
Dr. Khajavi e-mail address
What processes are involved for a request to access data/document