Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615063
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous IV cannulae in neonates The study involves neonatal patients requiring peripheral IV cannulation The main questions it aims to answer are
Does limb splinting increase the lifespan of IV cannulae compared to non-splinting What are the effects of splinting on the incidence of complications like extravasation occlusion and leakage Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannulas lifespan and reduces complications
Participants will
Undergo peripheral IV cannulation with and without limb splinting Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes
Does limb splinting increase the lifespan of IV cannulae compared to non-splinting What are the effects of splinting on the incidence of complications like extravasation occlusion and leakage Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannulas lifespan and reduces complications
Participants will
Undergo peripheral IV cannulation with and without limb splinting Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes
Detailed Description:
This randomized controlled trial aims to investigate the impact of limb splinting on the lifespan of intravenous IV cannulae in neonates The study is motivated by the need to enhance the efficacy and safety of peripheral IV cannulation in neonates who frequently require intravenous access for the administration of medications and fluids during hospitalization Peripheral IV cannulation although common is associated with a limited dwell time and various complications including extravasation occlusion and leakage which can lead to multiple cannulations and increased discomfort for neonates
The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula thereby reducing the frequency of cannulation and associated complications The trial involves 246 neonates randomly assigned to either the splint or non-splint group with an equal number of participants in each group
Neonates included in the study will undergo standard peripheral IV cannulation procedures with all cannulae being inserted by experienced medical staff under controlled conditions In the splint group the limb with the IV cannula will be immobilized using a splint while in the non-splint group the limb will not be splinted The time from cannula insertion to removal will be meticulously recorded for each neonate along with any complications that arise such as extravasation accidental dislodgment infiltration phlebitis leakage or occlusion
Data will be collected using a self-designed questionnaire ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality The study will employ rigorous statistical analysis including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups and Spearmans rank analysis to explore correlations between various parameters
The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy
The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula thereby reducing the frequency of cannulation and associated complications The trial involves 246 neonates randomly assigned to either the splint or non-splint group with an equal number of participants in each group
Neonates included in the study will undergo standard peripheral IV cannulation procedures with all cannulae being inserted by experienced medical staff under controlled conditions In the splint group the limb with the IV cannula will be immobilized using a splint while in the non-splint group the limb will not be splinted The time from cannula insertion to removal will be meticulously recorded for each neonate along with any complications that arise such as extravasation accidental dislodgment infiltration phlebitis leakage or occlusion
Data will be collected using a self-designed questionnaire ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality The study will employ rigorous statistical analysis including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups and Spearmans rank analysis to explore correlations between various parameters
The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy
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