Comparison of facility and complications of nasal intubation with and without Gum Elastic Bougie guided by Glidoscope in patients undergoing Maxillofacial Surgeries in Sina Hospital
Objectives: The aim of this study is assessing the effects of gum elastic bougie on Ease and complications of Nasotracheal intubation guided by Glidoscope.In addition, Trauma to soft tissue and Intubation time will be assessed.
Design: Patients between 15 to 65-year old, who agrees inclusion criteria, will be studied.160 patients, ASA class I and II who undergoes maxillofacial surgeries with general anesthesia and nasotracheal intubation,are equally and randomly put in control and case groups.
Setting and conduct: Nasotracheal intubation is done as standard method in control patients and with gum elastic bougie in case group.
Participants and major eligibility criteria: All patients who undergoes maxillofacial surgery and needs nasotracheal intubation are included in this study. Patients with difficult or compromised airway and coagulopathy will be excluded from this study.
Intervention: Intervention of this study is performing nasotracheal with Bougie guide.
Main outcome measures variables: Attempts to successful intubation, Trauma to soft tissue, Bleeding and rate of complications will be recorded and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309247604N1
Registration date:2014-08-15, 1393/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Ailar Ahangari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 8799
Email address
melikaahangari@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of facility and complications of nasal intubation with and without Gum Elastic Bougie guided by Glidoscope in patients undergoing Maxillofacial Surgeries in Sina Hospital
Public title
Nasal Intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergo maxillofacial surgeries who need nasotracheal intubation; age between 15 to 65; ASA class I and II.
Exclusion criteria: patient younger than 15-year-old; patients with difficult or compromised airway; patients who have restrictions in mouth opening; coagulopathy; patients who don't have neurosurgery permission for nasal intubation; cases who need size 6 of tracheal tube or less; emergency or non-elective surgery.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Central building of university, Ghods St., Keshavarz boulvard, Tehran.
City
Tehran
Postal code
Approval date
2014-06-10, 1393/03/20
Ethics committee reference number
92-03-30-23881-117261
Health conditions studied
1
Description of health condition studied
Nasotracheal Intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Need to use Magill Forceps
Timepoint
During intubation, After intervention
Method of measurement
using or not using Magill During intubation
2
Description
Effects of using Bougie in reducing numbers of attempts to nasal intubation
Timepoint
After Intubation
Method of measurement
Count the number of trials
Secondary outcomes
1
Description
Bleeding
Timepoint
During intubation, After intervention
Method of measurement
Observation and confirmation of anesthesiologist
2
Description
Need to use Direct Laryngoscopy via Machintosh Laryngoscope
Timepoint
During intubation, After intervention
Method of measurement
Use of Machintosh Laryngoscope for intubation
3
Description
Trauma to soft tissue of mouth and soft palate
Timepoint
During intubation, After intervention
Method of measurement
Observation and confirmation of anesthesiologist
4
Description
Total time of intubation
Timepoint
From begining to the end of intubation process
Method of measurement
chornometer
Intervention groups
1
Description
In case group, Nasal intubation will be guided by Glydoscope with bougie.
Category
Prevention
2
Description
In control group, Nasal intubation will be guided by Glydoscope without bougie.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Pejman Pourfakhr
Street address
Sina hospital, Hasan abad sq., Emam Khomeini st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Pejman Pourfakhr
Street address
Vice chancellor, Central building of Tehran univercity of medical science,Ghods st., Keshavarz Ave.
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 for 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 Sciences
Full name of responsible person
Ailar Ahangari
Position
Student of Medicine
Other areas of specialty/work
Street address
Sina hospital, Hasan abad sq., Emam Khomeini st., Tehran