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Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae

Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae; A Randomised Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06615063
Enrollment
246
Registered
2024-09-26
Start date
2022-12-10
Completion date
2023-10-10
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extravasation, Extravasation Injury, Intravenous Cannula Lifespan, Limb Splinting, Neonatal Peripheral Intravenous Cannulation

Keywords

Neonatal Care, Intravenous Cannulation, Splinting, Neonatal Surgery, Pediatric Surgery, Extravasation

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 cannula's 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 Spearman's 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.

Interventions

OTHERHasi's Splint

A splint made up of cotton and gauze piece rolled over a hard cardboard piece and covered by adhesive tape was applied to the limb immediately after fixing the cannula, as per the standardised method, to prevent movement at the underlying joint. Dimensions of the splints used were standardised as length extending two and a half inches on either side of the joint and width equal to the width of the limb just proximal to the joint.

Sponsors

Rawalpindi Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

The description of the study does not explicitly mention any masking (blinding). In the context provided, the primary investigator collects and analyzes the data using self-designed questionnaires. Typically, in such studies, the intervention (splinting) would be known to the participants and the healthcare providers administering the IV cannulation. Therefore, masking of the participants and providers might not be feasible.

Intervention model description

The interventional study model of the above article is a Parallel Assignment model. In this study, neonates are randomly assigned to one of two groups: one group receives the intervention (limb splinting) while the other group does not (non-splinted). The outcomes (e.g., lifespan of the IV cannula, incidence of complications) are then compared between these two parallel groups to determine the effectiveness of the intervention.

Eligibility

Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No

Inclusion criteria

* All neonates with intravenous cannulae

Exclusion criteria

* All neonates in neonatal ICU * All neonates with central venous line in place * All neonates that are on ventilatory support

Design outcomes

Primary

MeasureTime frameDescription
lifespan (dwell time) of the intravenous (IV) cannulae.from 0 to 48 hoursThe study aims to compare the mean dwell time of IV cannulae between the splinted and non-splinted groups to determine if limb splinting has a significant effect on extending the duration for which the cannula remains functional before removal.

Secondary

MeasureTime frameDescription
Incidence of Complicationsfrom 0 to 48 hoursVarious complications related to IV cannulation are assessed, including: Extravasation Accidental Dislodgment Infiltration Phlebitis Leakage Occlusion

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026