The comparison of success and side effects between standard nasotracheal intubation and bougie guide among mandible surgery patients reffered to poursina hospital in 2013
Nasotracheal intubation is often required for dental and oral surgery. In conventional nasal intubation, direct laryngoscopy using the Macintosh laryngoscope and Magill forceps or the fiberoptic bronchoscope is applied.
However, both of these methods are somewhat difficult to master by personnel who do not often perform nasotracheal intubation. The objective of this study was to assess effectiveness of gum elastic bougie (GEB) in nasotracheal intubation. The bougie is inexpensive, has few complications and is easy to use. We recommend that GEB should be
applied from the first attempt for nasal intubation in patients with mandibular truma.60 adult, ASA physical status 1 and 2 patients requiring nasotracheal intubation for mandibular surgery devided in two group randomized. The first group will intubated with standard nasotracheal approach and nasal intubation in the second group do with bougie guide. At first bougie passed the nose and enters to trachea with Macintosh laryngoscope and Magill forceps guide then tracheal tube is rdmy over the bougie into the trachea and bougie is removed.
All of the preoperative preparation And induction process is aqual in tow groups and some items such as success rate and complications should be registered inclouding oxygen desaturation, heart rate changes, time of intubation, attemps of intubation, nose truma, need to tube exchange and cuff rupture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306086280N3
Registration date:2013-09-07, 1392/06/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-10-08, 1392/07/16
Expected recruitment end date
2014-09-07, 1393/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of success and side effects between standard nasotracheal intubation and bougie guide among mandible surgery patients reffered to poursina hospital in 2013
Public title
Comparison of success and morbidity in both standard and ways in nasotracheal intubation bougie in patients with mandibular surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 60 years old; ASA I,II; surgical intubation for nasotracheal intubation; GCS:15 and neurosurgery visit; normal PT,PTT and PLT.
Exclusion criteria: sinusitis; nasal deformity or trauma and patient dissatisfaction.
Age
From 20 years old to 60 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193833697
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
1920101205
Health conditions studied
1
Description of health condition studied
Nasotracheal intubation
ICD-10 code
N42.3
ICD-10 code description
Dysplasia of prostate Low grade dysplasia
Primary outcomes
1
Description
Oxygen desaturation rate
Timepoint
During intubation
Method of measurement
Pulse Oximeter/%
2
Description
Heart rate variations
Timepoint
During intubation
Method of measurement
Monitoring / number
3
Description
Intubation duration
Timepoint
From starting endotracheal intubation to correctly position
Method of measurement
Second/ Capnograph
4
Description
Attempts to intubation times
Timepoint
During intubation
Method of measurement
Times
5
Description
Nose trauma
Timepoint
During extubation
Method of measurement
Visual/ Blood in throat or on the cuff
6
Description
Tracheal tube change
Timepoint
During intubation
Method of measurement
Tube exchange to a smaller size
7
Description
Cuff ruptured
Timepoint
During intubation
Method of measurement
Visual/No filled cuff after intubation
Secondary outcomes
empty
Intervention groups
1
Description
Nasotracheal intubation group or a control group that is standard procedure and does not interfere
Category
Prevention
2
Description
Intervention group nasotracheal intubation is performed with bogies
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Mohamad Haghighi
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abdolrasool Sobhani
Street address
Shahid Beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?