Background and Objective:
Laryngoscopy and tracheal intubation are performed by either direct laryngoscopy or video laryngoscopy. Video laryngoscopy complications in elderly patients have remained unknown. In this study complications of these two methods of laryngoscopy were compared in old patients.
Materials and Methods:
This study is a clinical trial. A total of 60 patients over 65 who scheduled for elective surgery are divided into two groups of video laryngoscope or Macintosh laryngoscope.
Inclusion criteria
1- ASA Class (American society of anesthesiology status)1 or 2
2- Age over 65 years
3- Patients undergoing any elective surgery requiring general anesthesia
4- Absence of cardiovascular, respiratory, neuromuscular and coagulopathy disease
5- Absence of high aspiration risk
6- No history of difficult intubation
7- Not probability of difficult intubation in a clinical examination
exclusion criteria
1- Vomiting and aspiration during anesthesia and laryngoscopy
2- cardiac arrest during anesthesia and laryngoscopy
In each patient, duration of laryngoscopy, tracheal tube insertion time, number of attempts for intubation, heart rate, systolic, diastolic and mean arterial pressure prior to induction of anesthesia and one minute after intubation are recorded. Finally, the two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409295363N4
Registration date:2014-10-04, 1393/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Science
Expected recruitment start date
2014-06-27, 1393/04/06
Expected recruitment end date
2014-12-27, 1393/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between direct laryngoscopy and video laryngoscopy complications in patients over 65 years old
Public title
video laryngoscopy complications in people over 65 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1- ASA Class (American society of anesthesiology status)1 or 2
2- Age over 65 years
3- Patients undergoing any elective surgery requiring general anesthesia
4- Absence of cardiovascular, respiratory, neuromuscular and coagulopathy disease
5- Absence of high aspiration risk
6- No history of difficult intubation
7- Not probability of difficult intubation in a clinical examination
exclusion criteria
1- Vomiting and aspiration during anesthesia and laryngoscopy
2- cardiac arrest during anesthesia and laryngoscopy
Age
From 65 years old
Gender
Both
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Zanjan University of Medical Science
City
Zanjan
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
A-11-511-3
Health conditions studied
1
Description of health condition studied
Anesthesiology
ICD-10 code
Y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents
Primary outcomes
1
Description
Heart rate changes
Timepoint
Before induction of anesthesia , and a minute later
Method of measurement
Pulse oxymeter
2
Description
Systolic blood pressure changes
Timepoint
Before induction of anesthesia , and a minute later
Method of measurement
Non -invasive blood pressure
3
Description
Diastolic blood pressure changes
Timepoint
Before induction of anesthesia , and a minute later
Method of measurement
Non -invasive blood pressure
4
Description
Mean blood pressure changes
Timepoint
Before induction of anesthesia , and a minute later
Method of measurement
Non -invasive blood pressure
5
Description
Duration of laryngoscopy
Timepoint
Arrival time of the laryngoscope into the mouth until endotracheal tube pass through the vocal cord
Method of measurement
Chronometer
6
Description
Number of intubation attempts
Timepoint
Number of attempts to enter the trachea tube into the trachea of the patient
Method of measurement
Observation
7
Description
Sore throat
Timepoint
The patient complained of sore throat
Method of measurement
Question
Secondary outcomes
empty
Intervention groups
1
Description
Laryngoscope, blade Makin Tash, Number 3
Category
Treatment - Other
2
Description
Video laryngoscope, blade number3
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi Hospital
Full name of responsible person
Dr Taraneh Naghibi
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan, Iran
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research of Zanjan University
Full name of responsible person
Alireza Biglari MD, PhD
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences
City
Zanjan
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 Zanjan University
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr shermin Gharanfoli
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Blvd
City
Zanjan
Postal code
Phone
+98 24 3326 7599
Fax
Email
shermingh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship- Assistant Professor
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24331472865
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship- Assistant Professor
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Blvd, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3347 2865
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)