Can Habitus Adapted Length Based Body Weight Estimation be Improved by Adding Further Parameters?

Weight-Estimation Clinical Trial

— Including MUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930928
• Other study ID #: KEK-ZH-Nr. 2015-0191 - Part 4
• Status: Completed
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2020
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: December 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight-Estimation

Intervention

Other:
• Accuracy of weight estimation
Computer based comparison

Locations

Country	Name	City	State
Switzerland	University Childrens Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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