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IRCT20210505051197N2 IRCT 2023-09-26 Shahid Beheshti University of Medical Sciences Comparing the two different methods of the internal jugular central venous catheter in infants under one-month-old Comparing the two different methods of the internal jugular central venous catheter in infants under one-month-old 2023-10-07 anticipated 64 Complete https://irct.ir/trial/72764 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization, Blinding description: Patients and their families were blinded to group allocation. Also, the data analyzer was blinded to the assigned group. N/A During aspiration, puncture and other catheterization. Intervention 1: Intervention group: Needle (22 G) catheterizations. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein. Intervention 2: Intervention group: Angiocath (22 G) catheterization. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein. No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding the ethical issues
public Alireza Mahdavi
Mofid Children's Hospital
Tehran Iran (Islamic Republic of) 15468 15514 +98 21 2222 7021 alirezamahdavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Alireza Mahdavi
Mofid Children's Hospital
Tehran Iran (Islamic Republic of) 15468 15514 +98 21 2222 7021 alirezamahdavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) infants under one month old who are candidates for central venous catheterization The lack of access to a suitable peripheral vein in critically ill babies who are hospitalized for a long time or need TPN (total parenteral nutrition) 1 day 30 days Both Central vein anomalies catheter site thrombosis catheter site infection Y60.6 During aspiration, puncture and other catheterization Treatment - Surgery Treatment - Surgery Intervention group: Needle (22 G) catheterizations. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein. Intervention group: Angiocath (22 G) catheterization. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein. The number of attempts for successful venipuncture. Timepoint: During the procedure. Method of measurement: Number. The time required for successful venipuncture. Timepoint: During the procedure. Method of measurement: minute. Shahid Beheshti University of Medical Sciences Approved 2022-07-24 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Velenjak Tehran Tehran Iran (Islamic Republic of)