Can Habitus Adapted Length Based Body Weight Estimation be Improved by Adding Further Parameters? (Including MUC)

November 9, 2020 updated by: University Children's Hospital, Zurich

Evaluation of an Algorithm for Gender Specific and Habitus Adapted Length Based Body Weight Estimation in Children - Improvement by Adding Another Parameter?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective single center study is performed at the university children's Hospital zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for CLAWAR. Patient and parental information is performed during the pre-anaesthetic visit.

After written consent the patient will be included. Patient ́s length and weight will be measures earliest one day before data collection. Data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in Microsoft Excel and statistical analysis calculated with SPSS.

500 patients are needed for a power of 80%. Primary outcome parameter is the accuracy of length based weight estimation using either patient habitus by visual estimation or an improved version of the algorithm CLAWAR using the mid upperarm circumference.

Study Type

Observational

Enrollment (Actual)

495

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

  • Switzerland
      • Zurich, Switzerland, 8051
        • University childrens 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

1 day to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients planned for elecitve surgery in general anaesthesia

Description

Inclusion Criteria:

  • body length suitable with the investigated algorithm
  • all patients aged 0 -16 years

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Accuracy of weight estimation
Computer based comparison of the two algorithms based on collected patient data
Other: Accuracy of weight estimation
Computer based comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length-based weight-estimation by algorithm
Time Frame: during procedure
Habitus adapted weight estimation based on visual habitus classification compared to weight estimation by the modified algorithm CLAWAR utilizing mid upperarm circumference
during procedure

Collaborators and Investigators

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

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Alexander R Schmidt, MD, University Children's Hospital Zurich, Department of Anaesthesia

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)

October 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2015-0191 - Part 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Weight-Estimation

Clinical Trials on Accuracy of weight estimation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe