Feasibility Determination of Nasogastric Tube Insertion in Conventional and SORT method
Design
Two hundred patients who need nasogastric tube insertion in emergency ward enter to study. Patients are randomly divided into two groups (100 patients in intervention, 100 patients in control) based on computer software. In the intervention group, the nasogastric tube will be inserted with SORT method. This method includes for steps. Sniffing position of the head and neck, inserting the nasogastric tube from one nostril, contra lateral rotation of head from the involved nostril, and twisting movement of the tube. In control group the nasogastric tube will be inserted with conventional method.
Settings and conduct
Emergency ward of Imam Reza (AS) hospital of Tabriz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Two hundred 18-60 years old patients who need nasogastric tube insertion in emergency ward.
Exclusion criteria: Neck spine disorders, loss of consciousness, dissatisfaction to participate to study.
Intervention groups
Intervention group: In this group, the nasogastric tube will be inserted with SORT method. This method includes for steps. Sniffing position of the head and neck, inserting the nasogastric tube from one nostril, contra lateral rotation of head from the involved nostril, and twisting movement of the tube. Control group: In this group, the nasogastric tube will be inserted with conventional method.
Main outcome variables
Number of attempts for Nasogastric tube insertion and pain severity at the time of its insertion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130224012592N5
Registration date:2018-07-21, 1397/04/30
Registration timing:registered_while_recruiting
Last update:2018-07-21, 1397/04/30
Update count:0
Registration date
2018-07-21, 1397/04/30
Registrant information
Name
Farzad Rahmani
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2078
Email address
rahmanif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of feasibility of Nasogastric Tube Insertion in Conventional and SORT method
Public title
Comparison of feasibility of Nasogastric Tube Insertion in two different methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old
Patients who need nasogastric tube insertion in emergency ward
Exclusion criteria:
Neck spine disorders
loss of consciousness
dissatisfaction to participate to study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
with RAS software
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.TBZMED.REC.1397.222
Health conditions studied
1
Description of health condition studied
Gastrointestinal hemorrhage
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal hemorrhage, unspecified
2
Description of health condition studied
Suicide attempt
ICD-10 code
T14.91
ICD-10 code description
Suicide attempt
Primary outcomes
1
Description
Number of attempts for Nasogastric tube insertion
Timepoint
At the time of insertion of the nasogastric tube
Method of measurement
Based on the number of attempts for Nasogastric tube insertion
2
Description
Pain severity at the time of insertion of the nasogastric tube
Timepoint
At the time of insertion of the nasogastric tube
Method of measurement
Based on numeric analog scale from 1 to 10
Secondary outcomes
1
Description
Complication at the time on nasogastric tube insertion
Timepoint
At the time on nasogastric tube insertion
Method of measurement
Based on patient's physical exam
Intervention groups
1
Description
Intervention group: In this group, the nasogastric tube will be inserted with SORT method. This method includes for steps. Sniffing position of the head and neck, inserting the nasogastric tube from one nostril, contra lateral rotation of head from the involved nostril, and twisting movement of the tube.
Category
Treatment - Devices
2
Description
Control group: In this group, the nasogastric tube will be inserted with conventional method
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza (AS) Hospital
Full name of responsible person
Hamed Afsharjou
Street address
Golgasht street, Azadi avenue, Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
farzadrhn@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Campus of Tabriz University, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golgasht Street, Tabriz University of Medical Science
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
rahmanif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golgasht Street, Tabriz University of Medical Science
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
rahmanif@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Rahmani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golgasht Street, Tabriz University of Medical Science
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
rahmanif@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I don't have any plan for publishing the data, now.