NCT02930928

Brief Summary

The purpose of this prospective single center study is to investigate if the accuracy of length based body weight estimation by the already investigated algorithm (CLAWAR) can be improved by adding another parameter. For this study 500 patients are required to collect anonymized data (length, weight, age, mid upperarm circumference and patient habitus by visual estimation) for achieving a power of 80% during statistical analysis. The main hypothesis ist that CLAWAR's accuracy can be improved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

October 10, 2016

Last Update Submit

November 9, 2020

Conditions

Weight-Estimation

Keywords

AnaesthesiaAnthropometryBody weight and measuresDevelopmentEmergency treatmentPatient safety

Outcome Measures

Primary Outcomes (1)

  • length-based weight-estimation by algorithm

    Habitus adapted weight estimation based on visual habitus classification compared to weight estimation by the modified algorithm CLAWAR utilizing mid upperarm circumference

    during procedure

Study Arms (1)

Accuracy of weight estimation

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

Other: Accuracy of weight estimation

Interventions

Accuracy of weight estimationOTHER

Computer based comparison

Accuracy of weight estimation

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 algorithm
  • all patients aged 0 -16 years

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

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander R Schmidt, MD

    University Children's Hospital Zurich, Department of Anaesthesia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

December 1, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)