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

September 25, 2024 updated by: Hasnain Aslam, Rawalpindi Medical College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Department of Pediatric Surgery,Holy Family Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splint Group
These neonates receive peripheral intravenous cannulation with limb splinting.
Other: Hasi'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.
No Intervention: Non-Splint Group
These neonates receive peripheral intravenous cannulation without limb splinting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lifespan (dwell time) of the intravenous (IV) cannulae.
Time Frame: from 0 to 48 hours
The 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.
from 0 to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Complications
Time Frame: from 0 to 48 hours

Various complications related to IV cannulation are assessed, including:

Extravasation Accidental Dislodgment Infiltration Phlebitis Leakage Occlusion
from 0 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rawalpindi Medical College

Investigators

  • Study Director: Ali Raza Chaudhry, MBBS, MS, Rawalpindi Medical College
  • Study Chair: Mudassar Fiaz Gondal, MBBS, MS, Rawalpindi Medical College
  • Principal Investigator: Hasnain Aslam, MBBS, Rawalpindi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2022

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMU-RRF-SUR-007-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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