Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465121
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-12
Brief Title:
Difficult Intravenous Access in Pediatric Patients Paramedical Care Using Ultrasound Guidance
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Difficult Venous Access in Pediatric Patients Paramedical Care Using Ultrasound Guidance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
VVParamECHO
Brief Summary:
Obtaining intravenous access is difficult in the pediatric population Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access compared to palpation of the vein alone
For this study when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient state-certified nurse investigators trained in ultrasound guidance will be contacted After verification of eligibility criteria and all informed consents obtained one of the investigators will randomize the patient in one of the 2 treatment groups under study peripheral intravenous catheterization by visualization and palpation of the vein alone standard of care or by ultrasound guidance performed by a trained nurse
Several outcomes will be measured and compared between the 2 groups eg successful insertion of intravenous catheter pain adverse events
For this study when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient state-certified nurse investigators trained in ultrasound guidance will be contacted After verification of eligibility criteria and all informed consents obtained one of the investigators will randomize the patient in one of the 2 treatment groups under study peripheral intravenous catheterization by visualization and palpation of the vein alone standard of care or by ultrasound guidance performed by a trained nurse
Several outcomes will be measured and compared between the 2 groups eg successful insertion of intravenous catheter pain adverse events
Detailed Description:
Venipunctures are very common in hospitalized patients Obtaining venous access is more difficult in the pediatric population particularly due to the smaller size of the vessels and the more difficult cooperation of patients Traditional method for inserting intravenous catheter access requires knowledge of vascular anatomy to estimate the location of the target vein and requires visualization or palpation of the vein The success rate for peripheral intravenous catheterization in pediatric patients is approximately 60 after one attempt and 90 after four Delays in intravenous access can result in significant morbidity and mortality Thus alternative methods should be considered to improve pediatric access sites
Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access This could also have an impact on the frequency of the main associated adverse events
For this study when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient state-certified nurse investigators trained in ultrasound guidance will be contacted After verification of eligibility criteria and all informed consents obtained one of the investigators will randomize the patient in one of the 2 treatment groups under study peripheral intravenous catheterization by visualization and palpation of the vein alone standard of care or by ultrasound guidance performed by a trained nurse
Several outcomes will be measured and compared between the 2 groups eg successful insertion of intravenous catheter pain adverse events
Children will be followed for a maximum of 7 days or until discharge from hospitalization
Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access This could also have an impact on the frequency of the main associated adverse events
For this study when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient state-certified nurse investigators trained in ultrasound guidance will be contacted After verification of eligibility criteria and all informed consents obtained one of the investigators will randomize the patient in one of the 2 treatment groups under study peripheral intravenous catheterization by visualization and palpation of the vein alone standard of care or by ultrasound guidance performed by a trained nurse
Several outcomes will be measured and compared between the 2 groups eg successful insertion of intravenous catheter pain adverse events
Children will be followed for a maximum of 7 days or until discharge from hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None