Objectives: Difficult laryngoscopy and intubation are scenarios in which the role of the anesthesiologist is pronounced. Most difficult intubation cases require the assistance of a peer in order to perform the required maneuvers for better intubation. The main outcome for the comparison of the impact of the two interventions would be the amount of changes in laryngoscopic view. The main goal of the current study is to compare laryngoscopic view and intubation conditions in "BURP"maneuver by laryngoscopist or laryngoscopist’s assistant. Design: All patients referring to the operating room will be included without any age limits. 80 people will be randomized into two 40 subject groups of control and intervention. Blinding will be performed on both laryngoscopist and his/her assistant. This study is a single center study. Methods: laryngoscopic view and intubation conditions in "BURP"maneuver by laryngoscopist and laryngoscopist’s assistant will be recorded and compared. Inclusion criteria: all patients undergoing elective surgeries under general anesthesia and tracheal intubation. Exclusion criteria: emergency surgeries; patients with head or neck or airway anomalies; patients with the previous history of difficult airway; patients with diagnosed airway masses; patients with the history of systemic diseases such as diabetes, rheumatoid arthritis etc.; patients with body mass index≥30. It is expected that, using this method, the speed and the success rate of the intubation in difficult intubation cases will increase through resolving the lack of coordination between the anesthesiologist and technician. In this randomized clinical trial, laryngoscopic view has been considered as the primary outcome of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012520795N1
Registration date:2016-05-01, 1395/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of laryngoscopic view and intubation conditions in "BURP"maneuver by laryngoscopist or laryngoscopist’s assistant
Public title
"BURP" maneuver and intubation conditions
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing elective surgeries under general anesthesia and tracheal intubation. Exclusion criteria: emergency surgeries; patients with head or neck or airway anomalies; patients with the previous history of difficult airway; patients with diagnosed airway masses; patients with the history of systemic diseases such as diabetes, rheumatoid arthritis etc.; patients with body mass index≥30.
Age
No age limit
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)
Single 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, Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
94.426
Health conditions studied
1
Description of health condition studied
Failed or difficult intubation
ICD-10 code
T88.4
ICD-10 code description
Primary outcomes
1
Description
Laryngoscopic view
Timepoint
Before and instantly after intervention
Method of measurement
Cormack- Lehane scoring and grading system
Secondary outcomes
1
Description
Intubation success rate
Timepoint
After intervention
Method of measurement
successful or unsuccessful intubation
Intervention groups
1
Description
BURP Maneuver performed by the technician in the intervention group
Category
Prevention
2
Description
BURP Maneuver performed by the specialist in the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Tabriz
City
Imam Reza Hospital, Golgasht St., Tabriz
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3556 6183
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 914 115 1894
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3556 6183
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)