The comparison of Miller and Macintosh blades laryngoscopy visualization for the removal of the foreign body from the hypopharynx with the Magill forceps
This study compares Miller and Macintosh laryngoscope for removing foreign body from hypopharynx area.
All candidates of esophagoscopy with the complain of foreign body in hypopharynx and esophagus who have more than 2 years old with ASA class 1, 2 and mallampati class 1, 2 are included. Sixty patients are divided randomly in two groups of blades: Miller and Macintosh
Laryngoscopic view will be recorded as the following:
1- Viewing larynx (vocal cords) without view of posterior part of piriform sinus
2- Viewing larynx (vocal cords) and the posterior part of piriform sinus
3- Viewing larynx (vocal cords) and the posterior part of piriform sinus and closed hypopharyngeal orifice
4- viewing larynx (vocal cords) and the posterior part of piriform sinus and open hypopharyngeal orifice
This study wants to answer to this question: which blade is more appropriate for removing foreign bodies from hypopharynx?
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072016917N3
Registration date:2014-09-12, 1393/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-12, 1393/06/21
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Miller and Macintosh blades laryngoscopy visualization for the removal of the foreign body from the hypopharynx with the Magill forceps
Public title
The comparison of Miller and Macintosh blades laryngoscopy for foreign body removal with Magill forceps in patients older than 2 years
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Age over 2 years; ASA class 1, 2
Exclusion criteria: Cormack and lehane score more than 2; Seeing wound or bleeding in hypopharynx
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random block
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1930075305
Health conditions studied
1
Description of health condition studied
Foreign body in pharynx
ICD-10 code
T17.2
ICD-10 code description
Foreign body in pharynx
Primary outcomes
1
Description
Carry out foreign body
Timepoint
After anesthesia
Method of measurement
success or failure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1) Miller blade, Riester company, Germany
Category
Treatment - Devices
2
Description
Intervention 2) Macintosh blade, Riester company, Germany
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Ali Ashraf
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Ali ashraf
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; aliashraf@gums.ac.ir
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; aliashraf@gums.ac.ir
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)