Overview

This trial is active, not recruiting.

Conditions length-based weight estimation, body weights and measures
Treatment device: accuracy of a program and the anesthesia tape ("anästhesie-lineal")
Sponsor University Children's Hospital, Zurich
Start date February 2016
End date February 2017
Trial size 500 participants
Trial identifier NCT02789930, KEK-ZH-Nr. 2015-0191 - Part 3

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").

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
length-based weight-estimation by program
time frame: intraoperative

Secondary Outcomes

Measure
length based age estimation
time frame: intraoperative
size of endotracheal tube
time frame: intraoperative
size of laryngeal mask
time frame: intraoperative
size of facemask
time frame: intraoperative
size of oropharyngeal tube
time frame: intraoperative

Eligibility Criteria

Male or female participants up to 16 years old.

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

Additional Information

Official title Evaluation of a Program for Length Based Weight Estimation in Comparison to 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Children's Hospital, Zurich.