Evaluation of an Algorithm for Length Based Weight Estima... | NCT02480413

Studies
Evaluation of an Algorithm for Length Based Weight Estimation

NCT02480413

Sponsor

University Children's Hospital, Zurich

Status

Completed

Last Update Posted

Apr 7, 2016Estimated

Enrollment

492Actual

Phase

Not provided

Conditions

Length Based Weight Estimation

Interventions

Accuracy of an algorithm and the pediatric emergency tape.

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 21, 2015

First Submission Date that Met QC Criteria

Jun 21, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2016

Last Update Posted Date

Apr 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Schmidt, Dr. med., University Children's Hospital, ZurichPrincipal Investigator

Lead Sponsor

University Children's Hospital, ZurichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

492Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Accuracy of an algorithm and the pediatric emergency tape.	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
length based weight estimation by algorithm		during anaesthesia

Secondary Outcomes

Measure	Description	Time Frame
length based age estimation		during anaesthesia
size of endotracheal tube		during anaesthesia
size of laryngeal mask

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

16 Years

Standard Ages

Child

Study Population

Pediatric patients planned for elecitve surgery in general anaesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander R Schmidt, MD	University Children´s Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Childrens Hospital		Zurich	Canton of Zurich	8051	Switzerland