Evaluation of Program for Length Based Weight Estimation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

Brief Summary

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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").

Detailed Description

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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.

Conditions

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Length-based Weight Estimation Body Weights and Measures

Keywords

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Weight estimation Patient safety

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Device: Accuracy of a program and the anesthesia tape ("Anästhesie-Lineal")

Computer based comparison of the two devices based on collected patient data

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Achim J Schmitz, M.D.

Role: STUDY_CHAIR

University Children's Hospital, Zurich

Locations

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University Childrens Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2015-0191 - Part 3

Identifier Type: -

Identifier Source: org_study_id