Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01279642
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2011-01-18
Brief Title:
Placement of Peripherally Inserted Central Venous Catheters PICC in Children Guided by Ultrasound
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
The Use of Doppler Vascular Ultrasound by Nurses During the Placement of Peripherally Inserted Central Venous Catheters in Children Clinical Randomized and Controlled Trial
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aimed to compare the success in the peripheral intravenous puncture PIP progression and placement of PICC in children according to the use of Doppler vascular ultrasound DVUS or traditional method to identify the influence of the DUVS in the time expended to PICC placement Methods Clinical randomized and controlled trial conducted after ethical merits of research endorsement and the obtaining of consent for those responsible for the children The sample calculated in 42 PICC to obtain a power of 085 was distributed randomly into two groups experimental group EG and controlled group CG To the statistical analyzes Pearson Chi-square Fishers Exact Tests Generalization of Fischers Exact and Mann-Whitney tests was applied 5 Of the 42 catheters 21 500 were implemented in EG and 21 500 in CG The PIP was obtained in the first attempt in 905 of the punctures of the EG and in 476 of the GC p0003 PICC were implanted successfully in 18 857 children of GE and 11 611 of CG p 0019 The median of the time spent to the procedure was significantly higher p0001 in CG 50 minutes when compared to EG median 20 minutes
Detailed Description:
Introduction Peripherally inserted central venous catheters PICC are increasingly being used to intravenous therapy in a wide variety of adults and pediatrics patients Children may have characteristics that could compromise the assertiveness during the catheter placement even for the more experienced and qualified professionals In order to search for methods that could lead to the nursing practice innovation seeking for better results in the placement of PICC this study was designed to analyze the use of Doppler vascular ultrasound DVUS to PICC insertion performed by nurses Objective To compare the success in the peripheral intravenous puncture PIP progression and placement of PICC in children according to the use of DVUS or traditional method to identify the influence of the DUVS in the time expended to the placement of PICC in children Methods Clinical randomized and controlled trial conducted in a pediatric surgery ward of a university hospital from August 17th 2007 to August 19th 2008 after ethical merits of research endorsement and the obtaining of consent for those responsible for the children The sample calculated in 42 PICC to obtain a power of 085 was distributed randomly into two groups experimental group EG and controlled group CG The dependent variables were the success in the PIP catheter progression and placement Variables related to children and IV therapy was investigated To the statistical analyzes Pearson Chi-square Fishers Exact Tests Generalization of Fischers Exact and Mann-Whitney tests was applied significance level of 5 Results Of the 42 catheters 21 500 were implemented in EG and 21 500 in CG The PIP was obtained in the first attempt in 905 of the punctures of the EG and in 476 of the GC p0003and the punctures were accomplished to catheter insertion despite the number of attempts in 765 of EG and 417 in GC p 0001 The successful to PICC progression was marginally significant result p0069 692 in EG and 440 in CG PICC were implanted successfully in 18 857 children of GE and 11 611 of CG p 0019 The median of the time spent to the procedure was significantly higher p0001 in CG 50 minutes when compared to EG median 20 minutes Conclusion The results obtained lead to the conclusion that the use of USVD to the implementation of the PICC in children promoted greater success in the PIP and in PICC placement reducing of the time spent to the procedure but no significant influence was observed regarding the catheter progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CNPq Grant nº 4762952004-1 | OTHER | National Council Scientific Development Brazil | None |