NCT02620540

Brief Summary

The purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are required to collect anonymized data (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist that the algorithm has a better accuracy than the BT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

November 17, 2015

Last Update Submit

May 25, 2018

Conditions

Weight-Estimation

Keywords

Broselow TapeWeight estimationPatient safety

Outcome Measures

Primary Outcomes (1)

  • length-based weight-estimation by algorithm

    The by the algorithm estimated bodyweight based on the patient's Body length is investigated regarding the estimations accuracy and cases in the +/- 10% interval

    during anaesthesia

Secondary Outcomes (5)

  • length based age estimation

    during anaesthesia

  • size of endotracheal tube

    during anaesthesia

  • size of laryngeal mask

    during anaesthesia

  • size of facemask

    during anaesthesia

  • size of oropharyngeal tube

    during anaesthesia

Interventions

Accuracy of an algorithm and the Broselow TapeDEVICE

Computer based comparison of the two devices based on collected patient data

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients planned for elecitve surgery in general anaesthesia

You may qualify if:

  • body length suitable with the investigated emergency tapes
  • all patients aged 0 -16 years
  • receiving general anaesthesia with intubation or laryngeal mask

You may not qualify if:

  • Already included in this study once
  • missing patient or parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Childrens Hospital

Zurich, 8051, Switzerland

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

December 3, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

November 1, 2017

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations

CH(1)