Evaluation of Program for Length Based Weight Estimation

Body Weights and Measures Clinical Trial

Official title:

Evaluation of a Program for Length Based Weight Estimation in Comparison to the Anesthesia Tape ("Anästhesie-Lineal")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789930
• Other study ID #: KEK-ZH-Nr. 2015-0191 - Part 3
• Status: Completed
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2020
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective single center study is to investigate if a developed program is more accurate than the anesthesia tape ("Anästhesie-Lineal"). For this study 1000 patients are required to collect anonymized data (length, weight, age, anesthesia material used during anesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist that the program has a better accuracy than the anesthesia tape ("Anästhesie-Lineal").

Description:

This prospective single center study is performed at the university children's Hospital zurich. Patients planned for surgery in general anesthesia 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-anesthetic 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 anesthesia has no influence on the daily anesthesia 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. 1000 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 anesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (program and anesthesia tape ["Anästhesie-Lineal"]) will be compared with each other regarding primary and secondary outcome parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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 anesthesia with intubation or laryngeal mask

Exclusion Criteria:

• Already included in this study once

• missing patient or parental consent

Related Conditions & MeSH terms

• Body Weight
• Body Weights and Measures
• Length-based Weight Estimation

Intervention

Other:
• Device: Accuracy of a program and the anesthesia tape ("Anästhesie-Lineal")
Computer based comparison of the two devices based on collected patient data

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 program	The by the program estimated bodyweight based on the patient's Body length is investigated regarding the estimations accuracy and cases in the +/- 10% interval	intraoperative
Secondary	length based age estimation	The by the program estimated age based on the patient's body length is investigated regarding the estimations accuracy	intraoperative
Secondary	size of endotracheal tube	The by the program suggested endotracheal tube based on the patient's Body length is investigated regarding the correctness	intraoperative
Secondary	size of laryngeal mask	The by the program suggested laryngeal mask based on the patient's Body length is investigated regarding the correctness	intraoperative
Secondary	size of facemask	The by the program suggested facemask based on the patient's body length is investigated regarding the correctness	intraoperative
Secondary	size of oropharyngeal tube	The by the program suggested oropharyngeal tube based on the patient's Body length is investigated regarding the correctness	intraoperative