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

NCT ID: NCT02930928

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

495 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Weight-Estimation

Keywords

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Anaesthesia Anthropometry Body weight and measures Development Emergency treatment Patient safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Accuracy of weight estimation

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

Accuracy of weight estimation

Intervention Type OTHER

Computer based comparison

Interventions

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Accuracy of weight estimation

Computer based comparison

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander R Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Zurich, Department of Anaesthesia

Locations

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University Childrens Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2015-0191 - Part 4

Identifier Type: -

Identifier Source: org_study_id