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Comparison of intubation time of jaw thrust maneuver versus transillumination in intubation by flexible fiberoptic laryngoscope in patients with elective surgeries.

Protocol summary

Summary
The aim of this study is comparing of jaw thrust maneuver versus transillumination of anterior neck in intubation by flexible fiberoptic laryngoscope. This is a randomized clinical trial on 90 patients aged 18 – 65 year who are selected for elective surgeries. Inclusion criteria: ASA classification of I and II, Body Mass Index (BMI) 20-25 (normal), mallampati score I or II. Exclusion criteria: patients with head and neck surgery and cesarean session, excessive obesity, cardiovascular diseases, high blood pressure, diabetes, cerebrovascular diseases. We divided these patients into three groups randomly: 1. Oral intubation by flexible fiberoptic laryngoscope (FFL) using jaw thrust maneuver and pulling tongue 2. Oral intubation by FFL using transillumination of anterior neck, without inspection through bronchoscope 3. Oral intubation by FFL using transillumination of anterior neck and inspection through bronchoscope. Duration of intubation from insertion of bronchoscope until the end of intubation and removal of bronchoscope from the mouth and connecting the capnograph to tracheal tube is calculated by chronometer. Moreover the number of time which SPo2 drops, bradycardia arises, and suctioning, reventilation and reintubation is needed, will be recorded. The maximum times of attempt for intubation is two times and if within 90 seconds intubation does not succeed the patient will be excluded. After the surgery in recovery room and ward patients will be questioned for sore throat, hoarseness and dysphagia and points will be given to the associated group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403069585N4
Registration date: 2014-05-27, 1393/03/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Ali Barkhori
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5803
Email address
a_barkhori@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intubation time of jaw thrust maneuver versus transillumination in intubation by flexible fiberoptic laryngoscope in patients with elective surgeries.
Public title
Comparison between jaw thrust maneuver and transillumination in intubation by flexible fiberoptic laryngoscope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA classification of I and II; Body Mass Index (BMI) 20-25 (normal); mallampati score I or II with thyromental interval of more than 6 cm with no difficulty of airway. Exclusion criteria: patients with head and neck surgery and cesarean session; excessive obesity; cardiovascular diseases; high blood pressure; diabetes; cerebrovascular diseases; GERD (acid reflux); history of consumption of medication which are influence heart rate and blood pressure and GI tract; and history of hoarseness; sore throat; and difficult intubation.
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The plan of anesthesia is explained for patients and after obtaining informed consent, they will be monitored completely, blood pressure is measured noninvasive and PETCO2 is measured by mainstream method. All intubation will be performed by a same person. The method of anesthesia for all of them is similar. Randomization is done by draw.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University Medical Sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
k/92/577

Health conditions studied

1

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

Primary outcomes

1

Description
Duration of intubation
Timepoint
from the time of bronchoscope insertion to the end of intubation
Method of measurement
by chronometer and the unit of second

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before induction, after induction and every minute for 5 minutes
Method of measurement
Monitoring device / mmHg

2

Description
Heart Rate
Timepoint
Before induction, after induction and every minute for 5 minutes
Method of measurement
Monitoring device / beat per minute

3

Description
Sore throat
Timepoint
After surgery
Method of measurement
Patient report of having or not having it

4

Description
Dysphagia
Timepoint
After surgery
Method of measurement
Patient report of having or not having it

5

Description
Hoarseness
Timepoint
After surgery
Method of measurement
Examination of the patient for having or not having it

Intervention groups

1

Description
In control group: oral intubation is performed by flexible fiberoptic laryngoscope made by Olympus company using jaw thrust maneuver and pulling tongue.
Category
Treatment - Devices

2

Description
Intervention in second group: oral intubation is performed by flexible fiberoptic laryngoscope made by Olympus company using transillumination of anterior neck without inspection through bronchoscope.
Category
Treatment - Devices

3

Description
Intervention in first group: oral intubation is performed by flexible fiberoptic laryngoscope made by Olympus company using transillumination of anterior neck with inspection through bronchoscope.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Jafar Salehi
Street address
Baghemelli Square
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Jafar Salehi
Position
َAssistant of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
dr.jsalehi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrdad Noroozi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
00
Fax
Email
javadkordi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Jafar Salehi
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
Baghemelli Square, Bahonar Hospital
City
Kerman
Postal code
Phone
00
Fax
Email
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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