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Comparing Magnet and Magill forceps in succes of nasal intubation of children

Protocol summary

Study aim
The overall purpose of this trial is to compare the use of Magnet with Magill forceps in success rate of children's nasal intubation. Specific puposes of the project include: 1) Measure the duration of intubation in both groups. 2) Compare the number of attempts to intubate between the two groups. 3) Determine changes in vital signs during intubation between the two groups.
Design
Clinical trials with control groups, with parallel groups,not blinded and randomized
Settings and conduct
The study will be conducted in the operating rooms of Tabriz Children's Hospital. Intubation in both groups is performed by expert anesthesiologist at children's anesthesia and the time of intubation will be also recorded by a second anesthetist in the questionnaire. The questionnaire contains basic patient information including sex, weight, age, vital signs and other variables .
Participants/Inclusion and exclusion criteria
Entry requirements include children aged 3 to 10 years old - ASA I, II - adenotonsillectomy candidates and non-entry conditions including underlying illness (cardiovascular, renal, coagulopathy), maxillofacial anomalies – past difficult airway history and parents' dissatisfaction .
Intervention groups
Patients in both groups will receive 2 μg / kg fentanyl, 1mg midazolam, 0.5mg / kg atracurium, 1mg / kg lidocaine, 3.5-4.5 mg / kg propofol and anesthetized, after dripping 2-3 drops of phenylephrine in the nasal hole the endotracheal tube will be impregnated with lidocaine gel and inserted to the nasopharynx. After laryngoscopy in the first group, Magill forceps and in the second group the Magnet will be used to guide the tube to trachea.
Main outcome variables
Age ; Weight ; Gender; Blood pressure ; Heart Rate ; O2 saturation; Number of attempts to intubate; Intubation time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100527004041N17
Registration date: 2019-07-23, 1398/05/01
Registration timing: prospective

Last update: 2019-07-23, 1398/05/01
Update count: 0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Magnet and Magill forceps in succes of nasal intubation of children
Public title
using magnet for nasotracheal intubation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
3-10 years old ASA l,ll adenotonsillectomy surgery candidate
Exclusion criteria:
underlying disease(cardio-vascular,renal,coagulopathy) maxillofacial anomalies previous difficult airway parental assent
Age
From 3 years old to 10 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
patients are classified randomly in two groups of intervention and control based on the form in randomization site.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethic committee of university, Research Vice chancellor of Tabriz University of Medical Sciences , Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TBZMED.REC.1398.127

Health conditions studied

1

Description of health condition studied
nasal intubation in pediatrics
ICD-10 code
ICD-10 code description

2

Description of health condition studied
adenotonsillectomy
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids

Primary outcomes

1

Description
intubation duration
Timepoint
during intubation
Method of measurement
watch

2

Description
number of attempts to intubate
Timepoint
during intubation
Method of measurement
counting

3

Description
Changes in vital signs
Timepoint
before induction ; after induction ; after intubation
Method of measurement
pulse oximeter ; cardiac monitoring blood pressure cuff

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 : Patients in both groups will receive 2 μg / kg fentanyl, 1mg midazolam, 0.5mg / kg atracurium, 1mg / kg lidocaine, 3.5-4.5 mg / kg propofol and anesthetized, after dripping 2-3 drops of phenylephrine in the nasal hole the endotracheal tube will be impregnated with lidocaine gel and inserted to the nasopharynx. After laryngoscopy in the first group, Magill forceps will be used to guide the tube to trachea.
Category
Other

2

Description
Intervention group: Patients in both groups will receive 2 μg / kg fentanyl, 1mg midazolam, 0.5mg / kg atracurium, 1mg / kg lidocaine, 3.5-4.5 mg / kg propofol and anesthetized, after dripping 2-3 drops of phenylephrine in the nasal hole the endotracheal tube will be impregnated with lidocaine gel and inserted to the nasopharynx. After laryngoscopy in the second group the Magnet will be used to guide the tube to trachea.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
operating room, Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Sheshgelan St , Tabriz Children Hospital,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2279
Email
kodakanhospital@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Jouyban
Street address
3rd floor,2th central building ,Tabriz university of medical sciences,Golgasht st,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan St ,Tabriz Children Hospital,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
Email
seidhejazie@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
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan St ,Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
Email
seidhejazie@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
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan St ,Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
Email
seidhejazie@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
Access will be 6 months after the results are printed.
To whom data/document is available
All Physicians and residents of the department of Anesthesia
Under which criteria data/document could be used
After obtaining permission from the deputy research of group
From where data/document is obtainable
Person responsible for scientific accountability of study
What processes are involved for a request to access data/document
First approved by the Research Vice-President
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