Comparing the Effectiveness of a Safety Intravenous Cannula With a Standard Intravenous Cannula in Neonates

NCT03597711 | Completed

• 1 other identifier: R04615
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A smaller caliber of intravenous cannulae decreases the number of thrombi and phlebitis and improves the duration of peripheral access. It also reduces the incidence of extravasation. 26G cannulae are easier to insert and reduce the number of attempts for cannulation. Safety cannulae are equivalent in terms of durability and ease of insertion, additionally providing a reduction in needle stick injury amongst healthcare professionals and patients. The goal of this study is to reduce the number of peripheral line insertions and resulting complications in neonates. The Investigators propose to compare 24G safety and 26G safety cannulae with non-safety 24G cannulae in infants \< 32 weeks Gestation and \< 1.5 kg weight in terms of length of stay of cannula, ease of insertion and rates of complications such as thrombosis, phlebitis and extravasation. The Investigators will also evaluate the frequency of needle stick injury to staff and patients in the course of the study.

Conditions

Preterm Infant

Keywords

Peripheral Intravenous cannulation

Outcome Measures

Primary Outcomes (1)

• length of stay of cannula

  How long the cannula continues to work

  Maximum of a week

Secondary Outcomes (2)

• ease of insertion

  Maximum of a week

• rates of complications

  Average of a week

Other Outcomes (1)

• frequency of needle stick injury

  At time of Insertion

Study Arms (3)

IVCannulation 24G non-safety cannula

ACTIVE COMPARATOR

Peripheral Intravenous cannulation using 24G non-safety cannula

Device: IVcannulation

IVCannulation 26G safety cannula

ACTIVE COMPARATOR

Peripheral Intravenous cannulation using 26G safety cannula

Device: IVcannulation

IVCannulation 24G safety cannula

ACTIVE COMPARATOR

Peripheral Intravenous cannulation using 24G safety cannula

Device: IVcannulation

Interventions

IVcannulation DEVICE

Peripheral venous cannulation is a common procedure on neonatal NICU, especially in preterm infants

Also known as: 24G non-safety cannula,26G safety cannula,24G safety cannula

IVCannulation 24G non-safety cannula; IVCannulation 24G safety cannula; IVCannulation 26G safety cannula

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates \< 32 Gestation
• \< 1.5 kg weight
• Admitted to NICU,St Mary's Hospital Manchester.

You may not qualify if:

• Neonates with severe skin conditions such as Epidermolysis Bullosa.
• Infants of \> 32 weeks Gestation
• \> 1.5 kg in birth weight. .Known difficult venous access (clinical decision). .Expected transfer to different neonatal or paediatric unit within 24hr of intended cannulation.
• Patients considered for reorientation of care or palliative care. .Infants previously recruited to the study who had a total of 3 episodes of randomization.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Neonatal Intensive Care Unit, St Mary's Hospital

Manchester, M13 9WL, United Kingdom

Location

Related Publications (3)

• Panadero A, Iohom G, Taj J, Mackay N, Shorten G. A dedicated intravenous cannula for postoperative use effect on incidence and severity of phlebitis. Anaesthesia. 2002 Sep;57(9):921-5. doi: 10.1046/j.1365-2044.2002.02786.x.

  PMID: 12190760 BACKGROUND

• Stokowski G, Steele D, Wilson D. The use of ultrasound to improve practice and reduce complication rates in peripherally inserted central catheter insertions: final report of investigation. J Infus Nurs. 2009 May-Jun;32(3):145-55. doi: 10.1097/NAN.0b013e3181a1a98f.

  PMID: 19444022 BACKGROUND

• Gupta P, Rai R, Basu S, Faridi MM. Life span of peripheral intravenous cannula in a neonatal intensive care unit of a developing country. J Pediatr Nurs. 2003 Aug;18(4):287-92. doi: 10.1016/s0882-5963(03)00052-6.

  PMID: 12923741 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anna Pawleletz

  Manchester University Foundation Trust, Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Once consent is obtained, patients will be randomized to either 24G non-safety cannula, 24G safety or 26G safety cannula. Each patient can enter the study a maximum of three times providing 90 episodes of cannulation.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 24, 2018
• Study Start: June 20, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)