NCT02789930

Brief 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").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

May 30, 2016

Last Update Submit

November 9, 2020

Conditions

Length-based Weight EstimationBody Weights and Measures

Keywords

Weight estimationPatient safety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • length based age estimation

    intraoperative

  • size of endotracheal tube

    intraoperative

  • size of laryngeal mask

    intraoperative

  • size of facemask

    intraoperative

  • size of oropharyngeal tube

    intraoperative

Interventions

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

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

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients planned for elecitve surgery in general anesthesia

You may qualify if:

  • body length suitable with the investigated emergency tapes
  • all patients aged 0 -16 years
  • receiving general anesthesia with intubation or laryngeal mask

You may not qualify if:

  • Already included in this study once
  • missing patient or parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Childrens Hospital

Zurich, 8051, Switzerland

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Achim J Schmitz, M.D.

    University Children's Hospital, Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 3, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CH(1)