Evaluation of an Algorithm for Length Based Weight Estimation

Length Based Weight Estimation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480413
• Other study ID #: KEK-ZH-Nr. 2015-0191 - Part 1
• Status: Completed
• Phase: N/A
• First received: June 21, 2015
• Last updated: April 6, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Length Based Weight Estimation

Intervention

Other:
• Accuracy of an algorithm and the pediatric emergency tape.
No intervention

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		during anaesthesia	No
Secondary	length based age estimation		during anaesthesia	No
Secondary	size of endotracheal tube		during anaesthesia	No
Secondary	size of laryngeal mask		during anaesthesia	No
Secondary	size of facemask		during anaesthesia	No
Secondary	size of oropharyngeal tube		during anaesthesia	No