Evaluation of an Algorithm for Length Based Weight Estimation

NCT ID: NCT02480413

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-03-31

Brief 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).

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.

Conditions

Length Based Weight Estimation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Accuracy of an algorithm and the pediatric emergency tape.

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Alexander Schmidt

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander R Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

University Children´s Hospital Zurich

Locations

University Childrens Hospital

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

KEK-ZH-Nr. 2015-0191 - Part 1

Identifier Type: -

Identifier Source: org_study_id