Evaluation of an Algorithm for Length Based Weight Estimation

Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Pediatric Emergency Tape (Pädiatrisches Notfalllineal - PNL)

The purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K., Falkenberg, Germany). 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 pediatric emergency tape (53% are in a +/- 10% interval).

Study Overview

• Status: Completed
• Conditions: Length Based Weight Estimation
• Intervention / Treatment: Other: Accuracy of an algorithm and the pediatric emergency tape.

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 pediatric emergency tape) will be compared with eachother regarding primary and secondary outcome parameters.

• Study Type: Observational
• Enrollment (Actual): 492

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8051
    • University Childrens Hospital

Participation Criteria

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
length based weight estimation by algorithm	during anaesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
length based age estimation	during anaesthesia
size of endotracheal tube	during anaesthesia
size of laryngeal mask	during anaesthesia
size of facemask	during anaesthesia
size of oropharyngeal tube	during anaesthesia

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Alexander R Schmidt, MD, University Children´s Hospital Zurich

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 21, 2015
• First Submitted That Met QC Criteria: June 21, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Patient safety; Weight estimation; Broselow Tape
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: KEK-ZH-Nr. 2015-0191 - Part 1