Determining the effectiveness of a modified roll ramp on intubation of surgical candidates
Determining the effect of modified ramp roll on the number of attempts to successfully intubation
Determining the effect of modified ramp roll on duration of intubation
Determination and comparison of cormack lehane score in intubation of patients in the modified roll ramp group with the standard group
Design
Randomized, blind clinical trial. 112 patients were divided into two groups: case group(n = 56) and control group (n = 56).
Ps: //www.sealedenvelope.com/simple-randomiser/v1/lists will be used for randomization.
Settings and conduct
After obtaining a sampling permit, patients in the operating room of Beheshti Hospital in Qom who meet the inclusion criteria are asked for informed consent to enter the study. Then, by random sampling, patients are divided into control and intervention groups. Intubation by An anesthesiologist is performed and the data is prepared through a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 15 to 80 years
Mallampati patients score II-IV
Patients who will undergo non-emergency general anesthesia
Having informed consent to participate in the study
Criteria for not entering:
Patients undergoing local or spinal anesthesia
Patient dissatisfaction at any stage of the research
Restriction on positioning in modified RAMP position
History of any disease that causes instability of the cervical spine
Patients with limited neck extension and flexion movement
Patients with large neck masses
Intervention groups
After random sampling, in the intervention group ,patient supine on a modified RAMP as a trapezoidal device, and intubation is performed by an anesthesiologist.
Main outcome variables
Determining the effectiveness of modified roll ramp on intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220511054817N1
Registration date:2022-05-22, 1401/03/01
Registration timing:registered_while_recruiting
Last update:2022-05-22, 1401/03/01
Update count:0
Registration date
2022-05-22, 1401/03/01
Registrant information
Name
Sourena Rezvani dehaghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2295 2912
Email address
sourena1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of successful endotracheal intubation between the " standard-method " and " Modified-ramped position"
Public title
Comparison of successful endotracheal intubation between the " standard-method " and " Modified-ramped position"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 15 and 80 years
Patients with Malampati Score 2 to 4
Patients who will undergo non-emergency general anesthesia
Having informed consent to participate in the study
Exclusion criteria:
Patients undergoing local or spinal anesthesia
Patient dissatisfaction at any stage of the research
Restriction of position in the modified ramp position
History of any disease that causes instability of the cervical spine
Patients with limited neck extension and flexion movement
Patients with large neck masses
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are easily entered into the study and randomly assigned to intervention and control groups. The site https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for random allocation of samples by randomized block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who meet the inclusion criteria enter the study after receiving full explanations about the research and how to conduct the research and obtain informed consent.Cases are divided into two groups of case and control by random sampling method.Intubation of both intervention and control groups is performed by an anesthesiologist and the data is collected and completed by an operating room technician who is not aware of the intervention and control group in the research through a checklist prepared by the researcher.Data analysis is performed by a statistical expert who is not aware of the intervention and control group in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Qom University of Medical Sciences
Street address
No. 20, Valiasr Ave., artesh Blvd., aqdasiyeh
City
Tehran
Province
Tehran
Postal code
1694733415
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.MUQ.REC.1401.010
Health conditions studied
1
Description of health condition studied
Intubation of surgical candidate patients
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Duration of intubation
Timepoint
At the beginning of the study
Method of measurement
Measuring intubation time in seconds (with the help of a blind person to the type of intervention)
2
Description
Number of attempts for successful intubation
Timepoint
At the beginning of the study
Method of measurement
Counting the number of times intubation (with the help of a blind person to the type of intubation intervention)
3
Description
Patient satisfaction
Timepoint
12 hours after surgery
Method of measurement
Based on the Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group (M), the patient is placed in a supine position on a modified RAMP (a trapezoidal device with a height of 15 cm, and a length of 80 cm, with an angle of 30 degrees, which has a length of 20 cm and 80 cm). .)At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale.
Category
Treatment - Devices
2
Description
Control group: n the control group (S), patients are usually placed in the supine position and a pillow 10 cm high is placed under the patient's head.At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Educational and Medical Center
Full name of responsible person
Sourena Rezvani dehaghani
Street address
No. 20, Valiasr Ave., artesh Blvd., aqdasiyeh
City
Tehran
Province
Tehran
Postal code
1694733415
Phone
+98 21 2295 2912
Email
Sourena1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza Koohpaei
Street address
No. 83, Shahod lotfi niyasar Ave., Safashahr Blvd
City
qom
Province
Ghoum
Postal code
93456-37169
Phone
+98 25 3285 2720
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Sourena Rezvani dehaghani
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 20, Valiasr Ave., Aqdasiyeh
City
Tehran
Province
Tehran
Postal code
1694733415
Phone
+98 21 2295 2912
Email
Sourena1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Sourena Rezvani Dehaghani
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 20, Valiasr Ave.,Artesh Blvd., Aqdasiyeh
City
Tehran
Province
Tehran
Postal code
1694733415
Phone
+98 21 2295 2912
Email
Sourena1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Sourena Rezvani dehaghani
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 20 , Valiasr Ave , Artesh Blv , Aqdasiyeh
City
Tehran
Province
Tehran
Postal code
1694733415
Phone
009822952912
Email
Sourena1374@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