Comparison of Nasal Intubation Based on the four Directions Behinds Facing Bevel of the Tip of the Tracheal Tube in Causing Complications and Epistaxis
Determining the comparison of the incidence of nosebleeds in patients with nasotracheal intubation and the average duration of intubation in each of the four groups.
Design
This study is a three-way blind clinical trial, in which 200 patients with eligibility conditions are selected and distributed into four groups of 50 people by random assignment software. Sampling is done by random random sampling available.. The rand function of Excel software is used for randomization.
Settings and conduct
. After initial oxygenation of the patient, anesthetics including lidocaine, fentanyl, propofol and Atrocorium will be injected to the patient. During masking, two drops of 0.5% phenylephrine swabs will be placed in each nostril of the patient to prevent nosebleeds.
the duration of intubation will be recorded for each time from the time of insertion into the nostril until the time of connecting the capnograph. . To measure the amount of bleeding, a four-point scale will be used, which is performed by an anesthesiologist based in the operating room and based on observation. To measure the difficulty of intubation, a three-point scale from one to three in the order of easy, medium, and hard is used
hemodynamic parameters including SpO2, heart rate, and blood pressure will be recorded
Participants/Inclusion and exclusion criteria
Entry criteria: patients over the age of 18; Perform nasotracheal intubation
Exclusion criteria: frequent nosebleeds; Coagulation disorder; Nasal foreign body; blood Hypertension; Severe deviation of the nasal septum
Intervention groups
In each group, the intervention is performed in one of the four directions of nasal intubation
Main outcome variables
average blood pressure, arterial blood saturation, heart rate; Difficulty of intubation: intensity of bleeding: occurrence of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N61
Registration date:2024-08-09, 1403/05/19
Registration timing:prospective
Last update:2024-08-09, 1403/05/19
Update count:0
Registration date
2024-08-09, 1403/05/19
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nasal Intubation Based on the four Directions Behinds Facing Bevel of the Tip of the Tracheal Tube in Causing Complications and Epistaxis
Public title
The effect of intubation direction on intubation complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18
Perform nasotracheal intubation
Exclusion criteria:
History of frequent bleeding from the nose
Coagulation disorder
Nasal foreign body
Hypertension
Severe deviation of the septum
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way. The samples are
randomly placed in four intervention groups 1, 2, 3, 4
by means of random allocation software. Sampling
continues until the samples in all four groups reach the
set limit
Blinding (investigator's opinion)
Triple blinded
Blinding description
After entering the operating room, the patients are not aware of which group they are placed in, and the researcher is not familiar with the names of the groups, and finally, the person who records the complications or assesses the secondary outcomes is not aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of School of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-05-30, 1403/03/10
Ethics committee reference number
IR.MUI.MED.REC.1403.088
Health conditions studied
1
Description of health condition studied
nose bleeding
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Mean Arterial Pressure
Timepoint
(before the start of the intervention) and minutes 3,6 and 9
Method of measurement
Non Invasive Blood Pressure
Secondary outcomes
1
Description
nose bleeding
Timepoint
Passing the tube into the trachea after passing through the nose
Method of measurement
Without blood, anemic, moderate and high
Intervention groups
1
Description
Intervention group: The duration of intubation for the Superior method will be from the time of insertion into the nostril until the time of capnography. Intubation will be performed by an anesthesiologist with 20 years of experience. To measure the amount of bleeding, a four-point scale will be used, which is performed by an anesthesiologist based in the operating room and based on observation. To measure the difficulty of intubation, a three-point scale from one to three in the order of easy, medium, and hard is used, and the data will be recorded based on the opinion of the anesthesiologist. Also, the hemodynamic parameters, which include SpO2, heart rate, and blood pressure at the base time and then every 3 minutes to 9 minutes after tracheal intubation, it will be recorded that the frequency of hypoxia (SpO2 less than 90%) will be recorded, also the ENT specialist will check the incidence of complications such as polyp rupture, nasal turbine rupture by nasoscope and bleeding in the areas of the nasopharynx, nasal inlet and oropharynx. .
Category
Prevention
2
Description
Intervention group: The duration of intubation for the Inferior method will be from the time of insertion into the nostril until the time of capnography. Intubation will be performed by an anesthesiologist with 20 years of experience. To measure the amount of bleeding, a four-point scale will be used, which is performed by an anesthesiologist based in the operating room and based on observation. To measure the difficulty of intubation, a three-point scale from one to three in the order of easy, medium, and hard is used, and the data will be recorded based on the opinion of the anesthesiologist. Also, the hemodynamic parameters, which include SpO2, heart rate, and blood pressure at the base time and then every 3 minutes to 9 minutes after tracheal intubation, it will be recorded that the frequency of hypoxia (SpO2 less than 90%) will be recorded, also the ENT specialist will check the incidence of complications such as polyp rupture, nasal turbine rupture by nasoscope and bleeding in the areas of the nasopharynx, nasal inlet and oropharynx. .
Category
Prevention
3
Description
Intervention group: The duration of intubation for the right lateral method will be from the time of insertion into the nostril until the time of capnography. Intubation will be performed by an anesthesiologist with 20 years of experience. To measure the amount of bleeding, a four-point scale will be used, which is performed by an anesthesiologist based in the operating room and based on observation. To measure the difficulty of intubation, a three-point scale from one to three in the order of easy, medium, and hard is used, and the data will be recorded based on the opinion of the anesthesiologist. Also, the hemodynamic parameters, which include SpO2, heart rate, and blood pressure at the base time and then every 3 minutes to 9 minutes after tracheal intubation, it will be recorded that the frequency of hypoxia (SpO2 less than 90%) will be recorded, also the ENT specialist will check the incidence of complications such as polyp rupture, nasal turbine rupture by nasoscope and bleeding in the areas of the nasopharynx, nasal inlet and oropharynx. .
Category
Prevention
4
Description
Intervention group: The duration of intubation for the left lateral method will be from the time of insertion into the nostril until the time of capnography. Intubation will be performed by an anesthesiologist with 20 years of experience. To measure the amount of bleeding, a four-point scale will be used, which is performed by an anesthesiologist based in the operating room and based on observation. To measure the difficulty of intubation, a three-point scale from one to three in the order of easy, medium, and hard is used, and the data will be recorded based on the opinion of the anesthesiologist. Also, the hemodynamic parameters, which include SpO2, heart rate, and blood pressure at the base time and then every 3 minutes to 9 minutes after tracheal intubation, it will be recorded that the frequency of hypoxia (SpO2 less than 90%) will be recorded, also the ENT specialist will check the incidence of complications such as polyp rupture, nasal turbine rupture by nasoscope and bleeding in the areas of the nasopharynx, nasal inlet and oropharynx. .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahara hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Akram Hemati
Street address
Kashani avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
hemati.akram@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Mortazavian
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mortazavian@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3822 2532
Email
behzad_nazem@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3822 2532
Email
behzadnazemroaya797@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Associate Professor/Faculty
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@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
Undecided - It is not yet known if there will be a plan to make this available