Quick stabilization of airway in damaged victims is a priority for pre-hospital care.
The aim of this study was to compare the effectiveness of laryngeal mask, oral pharyngeal and tracheal tube in the pre-hospital situation. Inclusion criteria: Patient’s GCS less than 9 and age greater than 18 years. Exclusion criteria: Impossibility of measuring hemodynamic responses before and after intervention. The study population: patients for whom intubation is not possible for any reason. They are randomly placed into groups: oral pharyngeal and laryngeal masks. Hemodynamic parameters are measured maximum after 10 minutes of the intervention. Sampling: 81 patients in 3 groups of people: Laryngeal mask, end tracheal tubes, oral and pharyngeal.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092310910N1
Registration date:2012-11-21, 1391/09/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-21, 1391/09/01
Registrant information
Name
Jalal Borna
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
jalal.borna@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal and Research Budget of Gonabad University of Medical Sciences
Expected recruitment start date
2012-12-31, 1391/10/11
Expected recruitment end date
2013-07-15, 1392/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effectiveness of airway management in pre-hospital
Public title
Effectiveness of laryngeal mask in airway management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Patient GCS less than 9; age greater than 18 years; without damage to the jaw and mouth; absence of pregnancy. Exclusion criteria: Impossibility of measuring hemodynamic responses before and after intervention.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Ethic committe of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Approval date
2012-08-08, 1391/05/18
Ethics committee reference number
الف/ک/91/3/1
Health conditions studied
1
Description of health condition studied
Victims patients requiring resuscitation
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
2
Description of health condition studied
cardiac patients requiring resuscitation
ICD-10 code
I46.9
ICD-10 code description
Cardiac arrest, unspecified
Primary outcomes
1
Description
Measurement of hemodynamic parameters
Timepoint
Twice, before and after insertion of airway devices
Method of measurement
Blood pressure control with pressure gauge،heart rate and blood oxygen with pulse oximetry
Secondary outcomes
1
Description
Duration of intervention
Timepoint
Twice, before and after intervention
Method of measurement
Timer
2
Description
Number of attempts
Timepoint
Befor insertion
Method of measurement
questionnaire
3
Description
Necessary to use the laryngoscope
Timepoint
befor insertion
Method of measurement
Questionnaire
4
Description
Technicians Satisfaction
Timepoint
after intervention
Method of measurement
questionnaire
5
Description
patient Coughing
Timepoint
after intervention
Method of measurement
questionnaire
6
Description
Patient gagging
Timepoint
befor intervention
Method of measurement
questionnaire
7
Description
Moving the patient's head
Timepoint
befor intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Effect of tracheal tube
Category
Prevention
2
Description
Effect of orophrengeal air way
Category
Prevention
3
Description
Effect of Laryngeal Mask air way
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Disaster and Emergency Medical Management Center
Full name of responsible person
Dr. Javad Bazeli
Street address
Next to the Bohlol Hospital
City
Gonabad
2
Recruitment center
Name of recruitment center
Disaster and Emergency Medical Management Center
Full name of responsible person
Dr. Hamed Jafarzade
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Gonabad University of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Jalal Borna
Position
MSc. Student
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 3028
Fax
Email
Jalal.borna@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 3401
Fax
+98 53 3722 3401
Email
khosravan@gmu.ac.ir
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Jalal Borna
Position
MSc student
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 3028
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)