The aim of this study is to find a new method for nasogastric intubation. for this purpose, 80 patients who are candidate for elective abdominal surgery and need nasogastric intubation will be randomly allocated into two groups. In the control group, the nasogastric tube will be inserted by conventional method with the head of the patients in neutral position after induction of anesthesia. In intervention group, a Nelaton catheter will be lubricated and inserted through the first proximal hole into the end of nasogastric tube. Then, the tube which have been equipped with a Nelaton catheter will be introduced via a nostirl and advanced through the nares and orogharynx into the esophagous with the head of patients in flexion position after induction of anesthesia. The success of nasogastric intubation will be confirmed by injection of 10 ML air into the tube and auscultation of epigastrium for air entrance. Success rate of the first trial will be recorded as the primary outcome measure.
General information
Acronym
----
IRCT registration information
IRCT registration number:IRCT201112023379N2
Registration date:2011-12-20, 1390/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Mehdi Ghaemi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1728 9915
Email address
mahiar@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan university of medical sciences
Expected recruitment start date
2011-12-06, 1390/09/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success rate of nasogastric intubation using a Nelaton catheter with conventional method of intubation in the patients under anesthesia
Public title
Comparison of success rate of nasogastric intubation using a Nelaton catheter with conventional method of intubation in the patients under anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients who are candidate for elective abdominal surgery and need nasogastric intubation, class 1&2 ASA clasification and age between 18 to 80 years
Exculution criteria: abnormal airway, difficult intubation, coagulopaty, esophagus disease and morbid obesity
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences
Street address
Azadi square
City
Zanjan
Postal code
4515613191
Approval date
2011-11-27, 1390/09/06
Ethics committee reference number
01-115-09/90
Health conditions studied
1
Description of health condition studied
Nasogastric intubation
ICD-10 code
k31.9
ICD-10 code description
Disease of stomach and duodenum,unspecified
Primary outcomes
1
Description
Success of nasogastric intubation
Timepoint
once- After induction of anesthesia and nasogastric tube insertion
Method of measurement
Injection of 10 ML air by gastric tube and ascultation of epigastrium
Secondary outcomes
1
Description
Tube coiling inside the oral cavity
Timepoint
once- After insertion of tube into nares
Method of measurement
observation of oral cavity
Intervention groups
1
Description
Intervention group: Nasogastric intubation using a tube which have been equipped with a Nelaton catheter in the neck flexion position under anesthesia
Category
Treatment - Drugs
2
Description
Control group: Nasogastric intubation by conventional method in neural position of the neck and head under anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valeiaser Hospital
Full name of responsible person
Dr. Mehdi ghaemi
Street address
Fazlollah Noori Aveneu
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ZAnjan University of Medical sciences
Full name of responsible person
Dr. mohammadreza seraj Sadeghi
Street address
Azadi Square
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ZAnjan University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical sciences
Full name of responsible person
Mehdi Ghaemi
Position
Assistant professor
Other areas of specialty/work
Street address
Vleiaser Hospital
City
Zanjan
Postal code
45157777978
Phone
+98 24 1727 0801
Fax
+98 24 1727 0751
Email
mahiar@zums.ac.ir - ghaemi_mp@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan university of Medical Sciences
Full name of responsible person
Mehdi Ghaemi
Position
Assistant professor
Other areas of specialty/work
Street address
Vlieaser Hospital
City
Zanjan
Postal code
45157777978
Phone
+98 24 1727 0801
Fax
+98 24 1727 0751
Email
mahiar@zuma.ac.ir ghaemi_mp@yahoo.com
Web page address
www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical sciences
Full name of responsible person
Mehdi Ghaemi
Position
Assistant professor
Other areas of specialty/work
Street address
Vlieaser Hospital
City
Zanjan
Postal code
45157777978
Phone
+98 24 1727 0801
Fax
Email
mahiar@zuma.ac.ir ghaemi_mp@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)