Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Known Devices

May 25, 2018 updated by: University Children's Hospital, Zurich

Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)

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.

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 the emergency tapes can be included in this study. 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 length- based weight estimation, secondary outcome parameters are length-based age estimation and the correctness of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (algorithm and BT) will be compared with each other regarding primary and secondary outcome parameters.

Study Type

Observational

Enrollment (Actual)

312

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 emergency tapes
  • all patients aged 0 -16 years
  • receiving general anaesthesia with intubation or laryngeal mask

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length-based weight-estimation by algorithm
Time Frame: during anaesthesia
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
length based age estimation
Time Frame: during anaesthesia
The by the algorithm estimated age based on the patient's body length is investigated regarding the estimations accuracy
during anaesthesia
size of endotracheal tube
Time Frame: during anaesthesia
The by the algorithm suggested endotracheal tube based on the patient's Body length is investigated regarding the correctness
during anaesthesia
size of laryngeal mask
Time Frame: during anaesthesia
The by the algorithm suggested laryngeal mask based on the patient's Body length is investigated regarding the correctness
during anaesthesia
size of facemask
Time Frame: during anaesthesia
The by the algorithm suggested facemask based on the patient's body length is investigated regarding the correctness
during anaesthesia
size of oropharyngeal tube
Time Frame: during anaesthesia
The by the algorithm suggested oropharyngeal tube based on the patient's Body length is investigated regarding the correctness
during anaesthesia

Collaborators and Investigators

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

Sponsor

University Children's Hospital, Zurich

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)

November 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2015-0191 - Part 2

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.

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