NCT06165003

Brief Summary

The patient's body weight is often taken as a basis when calculating drug doses and determining equipment sizes for pediatric patients presenting to the emergency department. The methods used to determine body weight are the family's estimated weight, formulas for estimating weight according to age, or the Broselow band used to estimate weight according to height. Weight estimates that are incomplete compared to the child's actual body weight lead to medication errors, wrong material selection and prolongation of the procedure, resulting in increased mortality and morbidity.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

November 25, 2023

Last Update Submit

December 8, 2023

Conditions

Keywords

broselow tapepediatric emergency departmentnurse

Outcome Measures

Primary Outcomes (1)

  • Selection by broselow Band

    Success of Broselow band selection

    2 year

Secondary Outcomes (3)

  • Nurses' success rate in catheter applications

    2 year

  • Nurses' success rate in catheter applications

    2 year

  • Nurses' success rate in catheter applications

    2 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Peripheral Intravenous Catheter Insertion Procedure - Broselow Band Selection - Experimental Group Urinary Catheter Insertion Procedure - Broselow Tape Selection - Experimental Group Aspiration process - Broselow Band Selection - Experimental group Nasogastric/Orogastric Catheter Insertion Procedure - Broselow Band Selection - Experimental Group

Other: Use of broselow tape

Control Group

NO INTERVENTION

Peripheral Intravenous Catheter Insertion Procedure - Routine Application - Control Group Urinary Catheter Insertion Procedure - Routine Application - Control Group Aspiration process - Routine Application - Control Group Nasogastric/Orogastric Catheter Insertion Procedure - Routine Practice - Control Group

Interventions

In the research, the nurse is the decision maker in the selection of the catheters to be used in the procedures (peripheral intravenous catheter insertion, urinary catheter insertion, aspiration procedure, nasogastric/orogastric catheter insertion) for the patients in the control group. In these procedures, the nurse's choices will be evaluated as control group data as routine clinical practice. After the control group data is collected, Broselow tape will be used in the selection of catheters to be used in the procedures to be performed on the patients in the experimental group (peripheral intravenous catheter insertion, urinary catheter insertion, aspiration procedure, nasogastric/orogastric catheter insertion). Our research will be conducted to examine the effect of nurses' use of Broselow tape in non-resuscitation applications and to minimize errors and application disruptions in procedures involving nurses.

Experimental group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children weighing 3 to 36 kg and 47 to 143 cm tall
  • Children aged 0-18
  • Patients coming to the emergency department for non-resuscitation procedures
  • Patients and their families who volunteer to participate in the research
  • Patients who will have a peripheral intravenous catheter inserted
  • Patients who will have a urinary catheter inserted
  • Patients who will have a nasogastric/orogastric catheter inserted
  • Patients who will undergo aspiration procedure

You may not qualify if:

  • Children weighing less than 3 kg and taller than 143 cm
  • Children with anomaly contractures that may prevent measurement during measurement with the Broselow tape
  • Patients with central venous catheter
  • Patients with peripheral intravenous catheters outside the pediatric emergency department
  • Patients who have a urinary catheter inserted outside the pediatric emergency department
  • Patients who have a nasogastric/orogastric catheter inserted outside the pediatric emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Argall JA, Wright N, Mackway-Jones K, Jackson R. A comparison of two commonly used methods of weight estimation. Arch Dis Child. 2003 Sep;88(9):789-90. doi: 10.1136/adc.88.9.789. No abstract available.

    PMID: 12937099BACKGROUND
  • Luscombe M, Owens B. Weight estimation in resuscitation: is the current formula still valid? Arch Dis Child. 2007 May;92(5):412-5. doi: 10.1136/adc.2006.107284. Epub 2007 Jan 9.

    PMID: 17213259BACKGROUND
  • Alaca A, Sari HY. An examination of how nurses' use of the Broselow tape affects patient safety during peripheral intravenous catheterization. Int Emerg Nurs. 2026 Feb;84:101712. doi: 10.1016/j.ienj.2025.101712. Epub 2025 Nov 25.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the research, control group data will be collected first. After the data of the control group is collected, the data of the experimental group will be collected.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

November 25, 2023

First Posted

December 11, 2023

Study Start

November 30, 2023

Primary Completion

June 26, 2024

Study Completion

December 26, 2025

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share