Protocol summary

Summary
The aim of this study is Effect of airway maneuvers on glottis visualization during video-laryngoscopy in patients under general anesthesia. Design: Prospective crossover clinical trial. Setting and conduct: Tertiary regional and teaching hospital. Participants including major eligibility criteria: In class I- III physical health classification of the American society of Anesthesia , undergoing general anesthesia in Rasoul Akram Hospital during 2015-2017, were included sequentially. Intervention: Each patient serving as his or her own control, and received Burp and Jaw Trust Maneuver. Main outcome measures (variables): Cormack and Lehane grading, Laryngoscopic view change. Type of maneuver are coded and delivered to the patients by and individual not aware of the research process.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201706035026N6
Registration date: 2017-06-16, 1396/03/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-16, 1396/03/26
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor research for Iran University Of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison score of laryngeal view in two facilitate laryngoscopy pressure Jaw thrust and BURP maneuvers during C-MAC video-laryngoscopy with blade D
Public title
Effect of airway maneuvers on glottis visualization during video-laryngoscopy
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: 104
Randomization (investigator's opinion)
N/A
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 Iran University Of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.IUMS.REC.1394.9211174008

Health conditions studied

1

Description of health condition studied
Failed or difficult intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
View of laryngeal inlet
Timepoint
Before and instantly after intervention
Method of measurement
Cormack- Lehane scoring and grading system

2

Description
change of laryngeal view
Timepoint
Before and instantly after intervention
Method of measurement
Cormack- Lehane scoring and grading system

Secondary outcomes

1

Description
The success rate of intubation
Timepoint
After intervention
Method of measurement
successful or unsuccessful intubation

Intervention groups

1

Description
Intervention group: Burp and Jaw Thrust maneuver
Category
Prevention

2

Description
Control group: Without the maneuver
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr. Masood Mohseni
Street address
Sattar Khan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor research of Iran University of Medical Sciences
Full name of responsible person
Mohammad Musavi
Street address
Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Masood Mohseni
Position
Associated professor of Anesthesiology
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21686702503
Fax
Email
masood.mohseni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Masood Mohseni
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Iran University Of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 212164352326
Fax
Email
masood.mohseni@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Masood Mohseni
Position
Associated Professor Of Anesthesiology
Other areas of specialty/work
Street address
Iran University Of Medical sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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