Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000578707
Ethics application status
Approved
Date submitted
29/05/2021
Date registered
19/04/2022
Date last updated
19/04/2022
Date data sharing statement initially provided
19/04/2022
Date results information initially provided
19/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does number of years of experience eliminate complications in vascular access?
Scientific title
Effect of Central Venous Catheter Insertion By Experienced Hands Using Anatomic Landmarks on Complications in Paediatric Patients
Secondary ID [1] 304354 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous catheterization 322128 0
Condition category
Condition code
Anaesthesiology 319831 319831 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A total of 498 patients in whom a port, Hickman or central venous catheter was inserted between 2014-2017 in the Operating Room of the Pediatric Surgery Department (Ege University School of Medicine) after obtaining the approval of the Hospital ethics committee (Ethics committee number: 18-9.1 / 32, Date: 18/09/2018) were included in this retrospective study. Patients' age, gender, height, weight, anesthesia method, type and size of the catheter, the catheterized vein, the number of punctures, the time to blood return (time from the beginning of the puncture to the control of blood flow from the catheter with aspiration as expressed in minutes), the short-term mechanical complications emerged during the insertion and follow-up to 24 hours post-operatively. All catheterizations were performed by anesthesiologists (faculty member, anesthesiologist or research assistant) using anatomic landmarks (without the guidance of ultrasonography) and Seldinger method after necessary sterile conditions were provided in the pediatric surgery operating room.
The anatomical region selected for the catheter insertion was determined taking into account the diagnosis of the patient, the operation to be performed, or the clinical condition of the patient. Subclavian, femoral, and internal jugular veins were preferred for catheterization. Propofol (2 mg/kg) was administered intravenously to patients with available intravenous access, and premedication with midazolam (0.75 mg/kg orally) was given for patients without intravenous access and patients were taken to the operating theater. Heart rate and rhythm, respiratory rate and oxygen saturation, noninvasive arterial pressure monitoring, end-tidal carbon dioxide monitoring were applied to the patients during the intervention. The catheter insertion site was left uncovered, and the procedure area was covered with a sterile drape. The catheter was inserted using the Seldinger technique and fixed with sutures. The location of the catheter was confirmed by fluoroscopy and anteroposterior chest radiography. The location of the catheter tip between the superior vena cava and the right atrium was accepted as an appropriate location. The pocket was created by the pediatric surgeon in port catheter applications.
Intervention code [1] 320709 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327702 0
To determine the complication rate in central catheter application.
Complications were determined as arrhythmia, arterial puncture, hemothorax, pneumothorax, and cardiac tamponade. Data were assessed by accessing the patient's medical record.
Timepoint [1] 327702 0
Assessed from the start of catheter insertion procedure to 24 hours post-insertion.
Secondary outcome [1] 396261 0
Risk factors associated with complications (Age, gender, BSA, the physician who first performed the catheterization, type of anesthesia applied, the type of catheter, the anatomical site used, the time to blood return, and the number of punctures were included in the model to determine the risk factors associated with complications). Data were obtained from the patient's medical record and the anesthesia form.

type of anesthesia applied (Data were obtained from the anesthesia form).
Timepoint [1] 396261 0
Assessed from the start of catheter insertion procedure to 24 hours post-insertion
Secondary outcome [2] 407297 0
type and size of the catheters (Data were obtained from the anesthesia form).
Timepoint [2] 407297 0
The intraoperative period
Secondary outcome [3] 407872 0
the catheterized veins (Data were obtained from the anesthesia form).
Timepoint [3] 407872 0
The intraoperative period
Secondary outcome [4] 407978 0
The success rate of catheterization (Data were obtained from the anesthesia form).
Timepoint [4] 407978 0
The intraoperative period
Secondary outcome [5] 408322 0
the number of punctures (Data were obtained from the anesthesia form).
Timepoint [5] 408322 0
the intraoperative period

Eligibility
Key inclusion criteria
the participants will only be eligible for inclusion if they had a port, Hickman or central venous catheter was inserted between 2014-2017 in the Operating Room of the Pediatric Surgery Department.
Minimum age
1 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The catheter inserted by ultrasonography

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
SPSS 23.0 (SPSS Inc., Chicago, Illinois, USA) program was used for statistical analysis. In the evaluation, numerical data were expressed as mean ± standard deviation, median (median), range of distribution (maximum-minimum), and categorical data as percentage (%). Pearson chi-square test was used to evaluate the differences between groups. The relationship between independent variables was analyzed using the independent t-test and the Mann-Whitney U test. ANOVA test and post hoc test (Bonferroni) were used for the evaluation of the success of the catheterization according to catheter insertion site. Logistic regression analysis was used to determine the independent risk factors associated with complications. The p=0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2018
Date of last participant enrolment
Anticipated
Actual
27/02/2019
Date of last data collection
Anticipated
Actual
27/02/2019
Sample size
Target
501
Accrual to date
Final
498
Recruitment outside Australia
Country [1] 23736 0
Turkey
State/province [1] 23736 0
Izmir

Funding & Sponsors
Funding source category [1] 296271 0
Self funded/Unfunded
Name [1] 296271 0
Cengiz Sahutoglu
Country [1] 296271 0
Turkey
Primary sponsor type
Individual
Name
Cengiz Sahutoglu
Address
Ege Universitesi Tip Fakultesi
Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100
Bornova/Izmir, Turkey
Country
Turkey
Secondary sponsor category [1] 309622 0
Individual
Name [1] 309622 0
Shahin Azizov
Address [1] 309622 0
Ege Universitesi Tip Fakultesi
Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100
Bornova/Izmir, Turkey
Country [1] 309622 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297506 0
Ege University Medical Research Ethics Committee
Ethics committee address [1] 297506 0
Ege University Medical Research Ethics Committee
Ege Universitesi Tip Fakultesi Dekanlik Binasi, 35100
Bornova/Izmir, Turkey
Ethics committee country [1] 297506 0
Turkey
Date submitted for ethics approval [1] 297506 0
27/08/2018
Approval date [1] 297506 0
18/09/2018
Ethics approval number [1] 297506 0
18-9.1/32

Summary
Brief summary
Central venous catheterization is a commonly used procedure in pediatric surgery and intensive care units. For some reasons, catheterizations in children are technically more difficult in comparison to adult patients. The purpose of this study is to evaluate the venous catheterization procedures performed with the aid of anatomic landmarks by experienced (35, 14, 4 years of experience) anesthesiologists and the associated complications. A total of 498 cases under the age of 18 who underwent central venous catheterization between the years 2014-2017 were included in this retrospective study. All catheters were inserted with the aid of anatomic landmarks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74262 0
Prof Taner Balcioglu
Address 74262 0
Ege University School of Medicine
Department of Anesthesiology and Reanimation, 35100
Bornova/Izmir, Turkey
Country 74262 0
Turkey
Phone 74262 0
+902323902140
Fax 74262 0
Email 74262 0
[email protected]
Contact person for public queries
Name 74263 0
Dr Shahin Azizov
Address 74263 0
Ege University School of Medicine
Department of Anesthesiology and Reanimation, 35100
Bornova/Izmir, Turkey
Country 74263 0
Turkey
Phone 74263 0
+902323902143
Fax 74263 0
Email 74263 0
[email protected]
Contact person for scientific queries
Name 74264 0
Dr Cengiz Sahutoglu
Address 74264 0
Ege University School of Medicine
Department of Anesthesiology and Reanimation, 35100
Bornova/Izmir, Turkey
Country 74264 0
Turkey
Phone 74264 0
+902323902143
Fax 74264 0
Email 74264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Local laws prohibit data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIDo not trust landmarks and your feelings while inserting pediatric central venous catheters2022https://doi.org/10.1186/s42077-022-00293-4
N.B. These documents automatically identified may not have been verified by the study sponsor.