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

Completed

• Conditions: Weight-Estimation

• Registration Number: NCT02620540
• Lead Sponsor: University Children's Hospital, Zurich

Brief Summary

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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-03
• Primary Completion: 2017-02
• Study Completion: 2017-11
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length-based weight-estimation by algorithm	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Childrens Hospital; 🇨🇭 Zurich, Switzerland