Comparison of the severity of epistaxis between the finger guided and conventional technique of nasotracheal intubation in patients undergoing maxillofacial surgeries
Determination of the severity of epistaxis in nasal endotracheal intubation with the help of finger guidance in the nasopharynx by endotracheal intubation in patients undergoing maxillofacial surgery
Design
This study is a double-blind randomized clinical trial performed on 68 patients undergoing maxillofacial surgery. Patients were randomly assigned to two groups using random allocation software.
Settings and conduct
In this study, the patient and the data collector were unaware of the study grouping
The place of study is in Al-Zahra Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 15-70 years; Candidate for elective maxillofacial surgery under general anesthesia; Lack of sensitivity to left or right nostrils; ASA One and Two; No history of snoring or sleep apnea; Lack of previous nasal diseases such as trauma, surgery, obstruction, and bleeding; Absence of coagulation disorders; Not taking medications that increase the risk of bleeding; No history of hypertension; Absence of obesity (BMI> 30); Exclusion Criteria: Unable to perform nasal intubation; Any change in the intubation technique; Doubt about Konka fracture
Intervention groups
We have two intervention groups
The first group was to guide the tube blind forward until the endotracheal tube was seen in the pharyngeal area following direct laryngoscopy with a Macintosh laryngoscope.
In the second group, after the finger of the non-dominant hand enters the mouth and then continues to the path to the back of the soft palate in the nasopharynx, move the endotracheal tube forward after contacting the tip of the endotracheal tube with the fingertip. The path of the endotracheal tube was done with the help of finger guidance and slowly until the endotracheal tube enters the space of the oropharynx.
Main outcome variables
Epistaxis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N15
Registration date:2020-09-21, 1399/06/31
Registration timing:retrospective
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2019-01-05, 1397/10/15
Actual recruitment end date
2019-08-25, 1398/06/03
Trial completion date
2019-08-27, 1398/06/05
Scientific title
Comparison of the severity of epistaxis between the finger guided and conventional technique of nasotracheal intubation in patients undergoing maxillofacial surgeries
Public title
Comparison of epistaxis in nasal tracheal intubation With finger guidance and conventional method
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective maxillofacial surgery under general anesthesia
ASA One and Two
Informed consent to participate in the study
Age: 16 to 65 years old
Exclusion criteria:
History of bleeding disorders
History of nasopharyngeal masses
History of head, face and fracture trauma of the nose and cheekbones
Taking any anticoagulant
History of any surgery or manipulation of the nose
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who entered the study were randomly divided into two groups using computer software (Random allocation software).
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who performed the intubation had no role in gathering information.
The person who assessing intubation complications and observer who collecting information were unaware of study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan Universiti of Medical Sciences
Street address
Sefa Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
IR.MUI.REC.1396.3.558
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
The severity of bleeding in the throat
Timepoint
After intubation through the nose
Method of measurement
See the throat
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The dominant or more open nostril (Patent) was selected by alternating finger pressure on the left and right nasal fins and asking the patient to take a slow breath. Then nasal tube number 7 in women and number 7.5 in men were used for intubation. The endotracheal tube was then inserted through the dominant (more open) nostril and directed to the pharynx. In the first group, the tube was guided blindly forward until the endotracheal tube was seen in the pharyngeal area following direct laryngoscopy with a Macintosh laryngoscope.
Category
Prevention
2
Description
Intervention group: In the second group, after the finger of the non-dominant hand enters the mouth and then continues to the back of the soft palate in the nasopharynx, We move the endotracheal tube forward So that after the tip of the endotracheal tube comes in contact with the tip of the finger, the end of the endotracheal tube path is guided by the finger and slowly until the endotracheal tube enters the oropharyngeal space. Then the endotracheal tube is guided to the endotracheal and if the accuracy of the intubation is ensured, the tube is fixed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Al-Zahra Hospital, Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2532
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjoo javanmard
Street address
Hizar jarib BLVD, Isfahan University of Medical Sciences and Health Services - Deputy of Research and Technology of the University
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2532
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital - Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2532
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2532
Email
hamidshetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use data to complete clinical trials
From where data/document is obtainable
Al-Zahra hospital
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of her research and the reason for using the data can be provided.