Determining the comparison of the complications of intubation through the conventional brouch nose with the ventilation method
Design
This study, it is a three-way blinded clinical trial in which 60 patients with eligibility conditions are selected and distributed into two groups of 30 by random assignment software. Sampling is done by random access sampling.
The first group or control intubation is performed through the nose and the second group is exposed to 100% oxygen during intubation.Phase 2 on 60patients. The rand function of Excel software was used for randomization.
Settings and conduct
The physical condition of the patient is also determined and recorded based on the ASA condition in the data collection form. On the day of surgery, the patients are examined and checked for the condition of the airway in order to intubate according to the Malampati criteria. Patients will not receive any anesthetic before entering the operating room. After entering the operating room, the patients are monitored including ECG, blood pressure and pulse oximetry, and vital signs including blood pressure, MAP, heart rate and oxygen saturation percentage are recorded. In both groups, intubation was performed by an experienced anesthesiologist. And the hemodynamic changes are registered by an anesthesiologist who is not involved in the study.
Participants/Inclusion and exclusion criteria
1. First and second class physical condition patients ASAI , ASAII
2. Age over 18 years
3. BMI less than 35
Non-Inclusion criteria:
1- Any anatomical disorder in the passage of the tube
2- Severe deviation of the septum
Intervention groups
In the control group, the usual procedure of intubation is performed through the nose.
In the intervention group, 100% oxygen is connected to the tracheal tube.
Main outcome variables
Mean blood pressure, Arterial blood saturation, Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N58
Registration date:2024-02-06, 1402/11/17
Registration timing:prospective
Last update:2024-02-06, 1402/11/17
Update count:0
Registration date
2024-02-06, 1402/11/17
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
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of conventional nasal intubation with ventilation during nasal intubation on hemodynamics and side effects
Public title
A comparison of intubation through the nose using the conventional method with ventilation during intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I , ASAII
Body Mass Index(BMI) <35
Exclusion criteria:
Severe deviation of the septum
Anatomical disorder in the passage of the tube
History of frequent bleeding from the nose
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 60 patients who meet the conditions for entering the study were selected and distributed into two groups of 30 people by random allocation software.
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
2024-01-13, 1402/10/23
Ethics committee reference number
IR.MUI.MED.REC.1402.386
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 1, 3 and 5
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: In order for hypoxia not to occur during the passage of the tracheal tube, the intervention group connected 100% oxygen to the connection of the tracheal tube by connecting a piece called "Way-like" in the respiratory circuit of the anesthesia machine, thus reducing the arterial oxygen saturation during the passage of the tracheal tube. We prevent.
Category
Prevention
2
Description
Control group: In the control group, conventional method because tracheal tube passage takes time, so there is a possibility of reducing the oxygen saturation of arterial blood, and if the pulse oximetry number is less than 89%, the patient may suffer from oxygen deficiency within 5 to 10 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Akram Hemati
Street address
Hezar Jarib
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?
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
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
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available