This study was performed to evaluate the effect of ultrasound training on the quality of radial artery catheterization in anesthesia residents.
Design
A clinical trial with a control group, with parallel, randomized groups, on 320 patients. For randomization, the permuted block randomization method will use quadratic blocks.
Settings and conduct
The patients were admitted to the operating room of the educational hospital and after randomization and general anesthesia, the resident corresponding to the patient group (the resident group with ultrasound experience or the resident group without ultrasound experience) placed the patient's wrist in the appropriate position and proceeded to Sterilization. Then this resident inserts the catheter into the artery at an angle of 30 degrees. At the same time, time recording is done using a stopwatch by the anesthesiologist in charge of the patient. After inserting the catheter and confirming its position with the return of pulsatile blood, the time recording ends. The catheter is fixed using suitable tape. The time spent, the success of the procedure, the number of catheters used, and possible complications are recorded in the questionnaire.
Participants/Inclusion and exclusion criteria
All patients older than 18 years who need arterial blood pressure monitoring for elective surgeries and have no contraindications for radial artery catheterization, who are admitted to the operating room at the time of the study.
Intervention groups
In the patients of the intervention group, catheterization will be performed by palpation method by residents who have learned this task with ultrasound. In the control group, catheterization by the palpation method will be performed by residents who have learned it by tactile method and have no experience working with ultrasound.
Main outcome variables
Success rate in the first attempt
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010800N5
Registration date:2022-08-12, 1401/05/21
Registration timing:prospective
Last update:2022-08-12, 1401/05/21
Update count:0
Registration date
2022-08-12, 1401/05/21
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-19, 1401/05/28
Expected recruitment end date
2023-02-16, 1401/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the radial artery catheterization success rates of first-year anesthesia residents who had or had not received ultrasonography practice.
Public title
Comparison of the radial artery catheterization success rates of first-year anesthesia residents who had or had not received ultrasonography practice.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Classification of patients' physical status according to the American Society of Anesthesiologists (ASA) one and two
Need to monitor arterial blood pressure for elective surgery
Exclusion criteria:
Dissatisfaction with participating in the study
Existence of any skin inflammation near the catheter entry site
Previous surgery near the catheter entrance
Abnormal result of the modified Allen test
History of radial artery catheterization in the past month
History of peripheral artery disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
320
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected for each resident by available sampling method. Patients are assigned to one of the two methods of palpation and radial artery catheterization based on the randomization sequence prepared using PASS software using the randomization method with permutation blocks with a block size of 4 with allocation (2x2). In randomization, each resident is considered as a stratum. Allocation of patients with this method will be done by an anesthesiologist who will not be involved in the next stages of the research and before the patient enters the operating room by opening the non-transparent sealed envelope containing the name of the group.
Blinding (investigator's opinion)
Double blinded
Blinding description
An anesthesia technician, who will not play a role in the research, will open an opaque sealed envelope based on a random sequence generated by the software during the patient's admission to the operating room and inform the responsible anesthesiologist. The anesthesiologist will call the resident associated with the patient group to perform catheterization and record the results of the resident's work. Then, without informing the main researcher, this information will be delivered to the statistical consultant of the project to be recorded in the statistical software.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.SBMU.REC.1397.010
Health conditions studied
1
Description of health condition studied
Increase the success rate of radial artery catheterization
ICD-10 code
4A133B1
ICD-10 code description
Monitoring of Arterial Pressure, Peripheral, Percutaneous Approach
Primary outcomes
1
Description
Success rate in the first attempt
Timepoint
The first 5 minutes of catheterization
Method of measurement
Measuring time and observing the success of anesthesia resident performance in radial artery catheterization by an anesthesiologist
Secondary outcomes
1
Description
Final success rate
Timepoint
During catheterization time
Method of measurement
An anesthesiologist observes the performance of the anesthesia resident
2
Description
The time taken to complete the catheterization
Timepoint
During catheterization time
Method of measurement
Measurement with a stopwatch by an anesthesiologist
Intervention groups
1
Description
Intervention group: Ten residents who each experienced ultrasound-guided catheterization in 16 patients in the first phase of the study will use the palpation method of radial artery catheterization in 16 other patients.
Category
Treatment - Devices
2
Description
Control group: Ten residents who each experienced the use of the palpation method in 16 patients in the first phase of the study will again use the palpation method for radial artery catheterization in 16 additional patients.