Comparison of the results of placing patients' heads in different positions during laryngoscopy in adult patients who are candidates for elective surgery: A randomized 3-arm clinical trial
Determine the most appropriate position of the patient's head to obtain the best vision and the least number of attempts to endotracheal intubatation
Design
Single blind Clinical trial, parallel group, randomized 150patients in three groups.
Settings and conduct
In this study, the nurse in charge of monitoring the patient (vital signs), the patients themselves, and the person in charge of analyzing statistical data from the patient group (head position) are unaware(blinded).
Participants/Inclusion and exclusion criteria
Inclusion: The patient is a candidate for elective surgery, the patient is 18 to 70 years old, the patient has a tracheal intubation indication for the operation. ASA class 1 and 2, the patient has no airway involvement, the patient has cervical spine disorder Do not have. The woman is not pregnant or breastfeeding.Exclusion : Jumping vomiting after induction of anesthesia, if the fourth blade requires for intubation. If out of 5 difficult intubation criteria, 4 criteria.
Intervention groups
Candidates for elective surgery are divided into three intervention groups including A, B, and C.Head positions that are given to all patients and then the doctor's view of their larynx is evaluated. A: The doctor extends the patient's head by applying pressure to the patient's forehead B: The patient's head using Bending downwards extends the bed series at an angle of 25 degrees. This angle will be measured for the whole patient by the executor and with a single instrument.C: Using a 7-cm rigid pillow, a sniff position is applied to the patient's head. One of the three positions is given to each patient, and the physician sees by performing laryngoscopy without manipulating the patient's larynx The neck is expressed and recorded through the validated percentage of glottis opening (POGO) score (zero to 100%).
Main outcome variables
First attempt Successful endotracheal intubation .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101114005175N20
Registration date:2022-04-26, 1401/02/06
Registration timing:prospective
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
Ali Movafegh
Name of organization / entity
Dr. Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
movafegh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of placing patients' heads in different positions during laryngoscopy in adult patients who are candidates for elective surgery: A randomized 3-arm clinical trial
Public title
Comparison of the results of placing patients' heads in different positions during laryngoscopy in adult patients who are candidates for elective surgery: A randomized 3-arm clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for elective surgery
The patient has an indication for endotracheal intubation.
Patients should be 18 to 70 years old
ASA class 1 and 2, the patient has no airway involvement, the patient has no cervical spine disorder.
Not pregnant or breastfeeding.
Exclusion criteria:
Jumping vomiting after induction of anesthesia
Requires blade laryngoscope number four for intubation
Existence of 4 criteria (out of 5 criteria) difficult intubation.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
155
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individual randomization is used. The sequence of random numbers is generated using "Randomization.com" website with simple randomization method. Finally, the patients are divided into three separate groups by sealed, opaque and sequenced envelopes. Envelopes are no different in size and color. These envelopes, which contain head position of patients are given to the researcher at the operation room. The researcher opens the numbers on the envelope in order for the eligible patients and assigns them to one of the three groups based on the pamphlets and descriptions inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the nurse in charge of monitoring the patient (vital signs), the patients themselves, and the person in charge of analyzing statistical data from the patient group (head position) are unaware(blinded).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences, School of Medicine
Street address
Keshavarz Blvd, Poorsina Alley
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.087
Health conditions studied
1
Description of health condition studied
Airway management in the operating room
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Head position of Successful intubation in the first attempt
Timepoint
After induction and proceed to intubation
Method of measurement
Direct laryngoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Patients are divided into three intervention groups. The anesthesiologist extends the patient's head by applying pressure to the patient's forehead. The anesthesiologist's vision is expressed and recorded by performing laryngoscopy with blade number 3 and without manipulating the patient's larynx from the neck, through the validated percentage of glottis opening (POGO) score (zero to 100%). A POGO score of 100% indicates a physician's complete view of the patient's larynx from the intraarthenoid incision to the anterior junction of the vocal cords, and a score of zero indicates no vision of the glottis opening.
Category
Treatment - Devices
2
Description
Intervention group B: The patient's head is extended by bending downwards at a 25-degree angle. This angle will be measured for the whole patient by the executor of the project with a single instrument. (Zero to 100%) is expressed and recorded. A POGO score of 100% indicates a physician's complete view of the patient's larynx from the intraarthenoid incision to the anterior junction of the vocal cords, and a score of zero indicates no vision of the glottis opening.
Category
Treatment - Devices
3
Description
Intervention group C: Using an inflexible 7-cm headband, a sniff position is applied to the patient's head. The physician's vision is expressed and recorded by performing laryngoscopy with blade number 3 and without manipulating the patient's larynx from the neck, through the validated percentage of glottis opening (POGO) score (zero to 100%). A POGO score of 100% indicates a physician's complete view of the patient's larynx from the intraarthenoid incision to the anterior junction of the vocal cords, and a score of zero indicates no vision of the glottis opening.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Ali Movafegh
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
movafegh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8822 1444
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ahang Karimi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Jalal Al ahmad Street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
ahang.karimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
movafegh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
movafegh@sina.tums.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Not all data can be shared.
When the data will become available and for how long
The access period will start 1 month after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutes, physicians specializing in anesthesia and intensive care, specialists in emergency medicine.
Under which criteria data/document could be used
Use of all the results and analyzes performed in the study by mentioning the exact source.
From where data/document is obtainable
Dr Ahang Karimi
ahang.karimi@yahoo.com
What processes are involved for a request to access data/document
The request will be sent within about 2 working weeks.