Comparison of RAMP position with modified RAMP position in laryngoscopic view during intubation of morbid obese patients for bariatric surgery.
Design
This study is a one-way blind controlled clinical trial on 84 patients in which patients are placed in groups using the block randomization method using a table of random numbers and adapting to blocks.
Settings and conduct
This study is performed in Hazrat Rasool Akram Hospital in Tehran, so that patients with morbid obesity who undergo bariatric surgery are positioned on the bed in two modified RAMP and RAMP, and airway intubation is performed for them. Patients are unaware of being in study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: greater than 35, No history of deformity in the head and neck, No lung disease, No history of drug use Exclusion criteria:History of heart disease, History of asthma, History of COPD
Intervention groups
In the first intervention group (RAMP), we provide for patients a soft pillow made of Surgical drapes and put it under the patient's head and shoulders in a supine position so that the patient's ear is in the direction of the sternum and in the modify RAMP group, a one-liter Normal Saline serum Prepare the and cover it completely with Underpads and place it the two shoulders of the patient and set the bed angle to 30 degrees.
Main outcome variables
Intubation time, need for support maneuver, amount of blood saturation at the end of Intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170109031852N5
Registration date:2020-05-07, 1399/02/18
Registration timing:registered_while_recruiting
Last update:2020-05-07, 1399/02/18
Update count:0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Mahzad Alimian
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
alimian.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of RAMP position with modified RAMP position in laryngoscopic view during intubation of morbid obese patients for bariatric surgery.
Public title
Comparison of RAMP position with modified RAMP position in laryngoscopic view during intubation of morbid obese patients for bariatric surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI greater than 35
No history of deformity in the head and neck
No lung disease
No history of drug use
The average age between 18-70 years
No history of difficult intubation
Exclusion criteria:
Patients with difficult airways
History of heart disease
History of asthma
History of COPD
History of obstructive sleep apnea
Malampati score more than 3
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results. .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.IUMS.FMD.REC.1399.050
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Intubation time
Timepoint
From the moment of starting the intubation to the end of the intubation
Method of measurement
Minutes
Secondary outcomes
1
Description
Blood O2 saturation after intubation.
Timepoint
After intubation
Method of measurement
Pulse oximeter
Intervention groups
1
Description
Intervention group one : In the RAMP group, the patient lies on the bed in a supine position and a standard pillow is made of surgical drapes and placed under the patient's head and shoulders so that the patient's ear is in the direction of the sternum and then anesthesia is done. After intubation, study variables are measured. This intervention is performed once for each patient
Category
Treatment - Devices
2
Description
Intervention group: In Modified RAMP group, the patient lies on the bed in supine position a one-liter Normal Saline serum Prepare the and cover it completely with underpads and place it the two shoulders of the patient and set the bed angle to 30 degrees and then anesthesia is done. After intubation, study variables are measured. This intervention is performed once for each patient
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Mahzad Alimian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6435 2326
Email
mahzadalimian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motavalian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6435 2326
Email
jhoseini2003@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
Associate r
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6435 2326
Email
mahzadalimian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ramin Ronasi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6435 2326
Email
Dr.r.rounasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ramin Ronasi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6435 2326
Email
Dr.r.rounasi@gmail.com
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available