Objective: Comparing intubation success rate in video laryngoscopy versus direct laryngoscopy in patients with Philadelphia collar. Design: Single-center prospective randomized controlled trial. Setting and Conduct: Dr.Shariati Hospital Operating Room. Participants: 172 patients with cervical collar undergoing surgery under general anesthesia will be enrolled. Inclusion criteria: patients with Philadelphia collar aged 18 to 60 years; American Society of Anesthesiologists physical status 1, 2. Exclusion criteria: musculoskeletal disorders; emergency surgery; impaired ventilation. Intervention: After entering the operating room, patients will be divided into two different groups named A and B based on the table of random numbers. Standard monitoring will be established for all the patients entering the operating room, induction of anesthesia will be given with 4 µg/kg fentanyl and 2.5 mg/kg and 1 mg stat propofol by an anesthesiologist, and 0.5 mg/kg atracurium will be used to facilitate the intubation. After induction of anesthesia for all patients, oral airway will be used to facilitate ventilation and the patient will be ventilated by bag and mask. After recording the Train of Four, video laryngoscope in Group A and Macintosh laryngoscope in Group B will be used for intubation. Variables: 1- Intubation time: time required for intubation; 2- Number of intubation attempts; 3- CORMACK of the patients; 4- Oral and dental injuries; 5- Coughing during extubation; 6- Complications during extubation including: soft tissue injuries; dental injuries; airway spasm; 7- Heart Rate, Blood Pressure (Baseline, 30 seconds and 1 and then 3 minutes after intubation); 8- Sore throat in patients in the ward.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062728668N1
Registration date:2016-08-23, 1395/06/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-23, 1395/06/02
Registrant information
Name
Amin Karami
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
_
Email address
a-karami@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research-Tehran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the intubation success rate in video laryngoscopy versus direct laryngoscopy in patients with philadelphia collar
Public title
The success rate of intubation in patients with neck injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with Philadelphia collar aged 18 to 60 years; american society of anesthesiologists physical status 1,2; surgery under general anesthesia
Exclusion criteria: diabetes mellitus; rheumatoid arthritis; obstructive sleep apnea; surgery on the head and neck; musculoskeletal disorders; poor oral health; emergency surgery; cardiovascular disease; having a beard; impaired ventilation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
172
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 Tehran University of Medical Sciences
Street address
Research deputy, Ethics Committee of Tehran University of Medical Sciences, 6th floor, Tehran University of Medical Sciences building, Ghods St,Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-05-03, 1395/02/14
Ethics committee reference number
IR.TUMS.REC.1395.2540
Health conditions studied
1
Description of health condition studied
intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
intubation success rate
Timepoint
after intubation
Method of measurement
capnograph and anesthesiologist's comment
Secondary outcomes
1
Description
Neck circumference
Timepoint
Before intubation
Method of measurement
Measuring with a meter tape
2
Description
heart rate
Timepoint
baseline; 30 seconds; 1 minute; 3 minutes after intubation
Method of measurement
device
3
Description
mean arterial pressure
Timepoint
baseline; 30 seconds; 1 minute; 3 minutes after intubation
Method of measurement
device
4
Description
CORMACK
Timepoint
During intubation
Method of measurement
through observation
5
Description
Duration of intubation
Timepoint
Method of measurement
chronometer
6
Description
number of intubation attempts
Timepoint
Method of measurement
anesthesiologist's comment
7
Description
oral and dental injury
Timepoint
After extubation
Method of measurement
Through observation
8
Description
cough during extubation
Timepoint
In the interval of 3 minutes after extubation
Method of measurement
Observation of coughing
9
Description
temporomandibular distance
Timepoint
Before intubation
Method of measurement
Measuring with a ruler
Intervention groups
1
Description
In control group intubations are done using direct laryngoscopy in which rigid laryngoscope is used to expose the laryngeal inlet under direct vision to facilitate intubation.
Category
Prevention
2
Description
in intervention group intubations are done using video laryngoscope. Video laryngoscope utilizes video camera technology to visualize airway structures and facilitate endotracheal intubation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research-Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Vice Chancellor for research , Tehran University of Medical Sciences Tehran Tehran, Islamic Republic Of Iran
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 of research-Tehran 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
Tehran university of medical science
Full name of responsible person
Dr. Amin Karami
Position
intern
Other areas of specialty/work
Street address
Tehran university of medical science, poursina St,Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 913 395 4606
Fax
Email
a-karami@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr Shariati Hospital
Full name of responsible person
Dr. Reza Atefyekta
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Dr Shariati Hospital, North Kargar Ave ,Amirabad
City
Tehran
Postal code
Phone
+98 911 331 0041
Fax
Email
atefyekta@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. Amin Karami
Position
intern
Other areas of specialty/work
Street address
Tehran university of medical science, poursina St,Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 913 395 4606
Fax
Email
a-karami@student.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)