Comparison the effect of selecting right or left nostril for nasotracheal intubation on incidence of complications in patient candidate for maxillofacial surgery
Comparison the effect of selecting right or left nostril for nasotracheal intubation on incidence of complications in patient candidate for maxillofacial surgery
Design
Clinical trial without a control group, with parallel, blinded, randomized groups
Settings and conduct
First, surgery is performed by alternately closing the open left and right nostrils, and nasotracheal intubation is routinely performed after induction of anesthesia. If the openness of the left and right nostrils is similar, one is performed through intubation through the left or right nostrils. The nostrils used by all patients will be recorded in their case file and a special form for each patient. Then the incidence of epistaxis, severity of bleeding in the area, incidence of intubation failure, incidence of concussion fracture, and mean duration of intubation in each patient will be recorded and recorded in a patient-specific form.
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 of those using the left nostril for nasotracheal intubation and the second group those using the right nostril for nasotracheal intubation
Main outcome variables
Incidence of epistaxis; severity of hemorrhage in the area; incidence of intubation failure; incidence of concussion fracture; mean duration of intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N9
Registration date:2019-08-29, 1398/06/07
Registration timing:prospective
Last update:2019-08-29, 1398/06/07
Update count:0
Registration date
2019-08-29, 1398/06/07
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
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of selecting right or left nostril for nasotracheal intubation on incidence of complications in patient candidate for maxillofacial surgery
Public title
Comparison the effect of selecting right or left nostril for nasotracheal intubation on incidence of complications in patient candidate for maxillofacial surgery
Purpose
Prevention
Inclusion/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
Age
From 15 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Isfahan Universiti of Medical Sciences
Street address
Feiz Hospital . Modares st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-12-15, 1397/09/24
Ethics committee reference number
IR.MUI.MED.REC.1397.306
Health conditions studied
1
Description of health condition studied
Maxillofacial Surgery
ICD-10 code
ICD-10 code description
maxillo
Primary outcomes
1
Description
Incidence of epistaxis
Timepoint
After surgery
Method of measurement
Observation
2
Description
severity of hemorrhage in the area
Timepoint
After surgery
Method of measurement
Examination
3
Description
incidence of intubation failure
Timepoint
After surgery
Method of measurement
Observation
4
Description
incidence of concussion fracture
Timepoint
After surgery
Method of measurement
Observation
5
Description
mean duration of intubation
Timepoint
Before surgery
Method of measurement
File
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using the left nostril for nasotracheal intubation
Category
Diagnosis
2
Description
Intervention group: using the right nostril for nasotracheal intubation
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 7539
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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres st.feiz hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3620 2020
Fax
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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
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
Undecided - It is not yet known if there will be 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
No - There is not 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
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Al-Zahra hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.