comparison of nasogastric tube (NGT) insertion by SORT maneuver compared to neck flexion lateral pressure in critically ill patients admitted to ICU
Design
Clinical trial with intervention and control groups, with parallel groups, Double-blind, randomized trial
Settings and conduct
All patients admitted to ICUs of Shohada and Imam Reza Hospitals , who are undergoing mechanical ventilation and require the insertion of NGT, will be included in this study. Patients will randomly be assigned to intervention and control groups to compare NGT insertion with SORT method and standard insertion method in these patients.
Participants and the person who will analyze the data collected during the study will be kept blind to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years old, need for NGT placement
Exclusion criteria: coagulopathy, skull base fracture, neck trauma, nose pathology
Intervention groups
Intervention group: NGT insertion by SORT method
Control group: NGT insertion by Neck flexion lateral pressure method
Main outcome variables
The success of insertion of NGT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002582N18
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nasogastric tube insertion by SORT maneuver and neck flexion lateral pressure in critically ill patients admitted to ICU.
Public title
Comparison of two different methods for insertion of nasogastric tube in critically ill patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Need for NGT insertion
Exclusion criteria:
Coagulopathy
Skull base fracture
Neck trauma
Nasal pathology
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned into two groups by block randomization.
Randomization is done based on the Grav O tron2.0 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants and the individual who analyzed the data collected during the study were kept blind to the study groups.
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
Central Building No. 2, Tabriz University of Medical Sciences, Golghast St,
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.TBZMED.REC.1396.839
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The success of insertion of NGT
Timepoint
After insertion of NGT
Method of measurement
Gastric auscultation after air injection
Secondary outcomes
1
Description
Time of NGT insertion
Timepoint
From the insertion of NGT to determining the correctness of the location
Method of measurement
Time taken from the insertion of NGT to determining the correctness of the location
Intervention groups
1
Description
Intervention group: NGT insertion with SORT method
Category
Treatment - Devices
2
Description
Control group: NGT insertion with neck flexion lateral pressure
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Golshahr Street, El-Goli Road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3336
Fax
+98 41 3389 3337
Email
amahmoodpoor@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza hospital, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
amahmoodpoor@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
Central Building No. 2, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Phone
+98 41 3335 7310
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
Kamran Shadvar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, Imam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4324
Email
k_shadvar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, Imam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4324
Email
amahmoodpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sarvin Sanaie
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Aging Research Institute, Faculty of Medicine, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 8626
Email
sarvin_so2000@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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study will be reported as paper
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document