- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789930
Evaluation of Program for Length Based Weight Estimation
November 9, 2020 updated by: University Children's Hospital, Zurich
Evaluation of a Program for Length Based Weight Estimation in Comparison to the Anesthesia Tape ("Anästhesie-Lineal")
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").
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8051
- University Childrens Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Pediatric patients planned for elecitve surgery in general anesthesia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length-based weight-estimation by program
Time Frame: intraoperative
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length based age estimation
Time Frame: intraoperative
|
The by the program estimated age based on the patient's body length is investigated regarding the estimations accuracy
|
intraoperative
|
size of endotracheal tube
Time Frame: intraoperative
|
The by the program suggested endotracheal tube based on the patient's Body length is investigated regarding the correctness
|
intraoperative
|
size of laryngeal mask
Time Frame: intraoperative
|
The by the program suggested laryngeal mask based on the patient's Body length is investigated regarding the correctness
|
intraoperative
|
size of facemask
Time Frame: intraoperative
|
The by the program suggested facemask based on the patient's body length is investigated regarding the correctness
|
intraoperative
|
size of oropharyngeal tube
Time Frame: intraoperative
|
The by the program suggested oropharyngeal tube based on the patient's Body length is investigated regarding the correctness
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Achim J Schmitz, M.D., University Children's Hospital, Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
May 30, 2016
First Submitted That Met QC Criteria
June 2, 2016
First Posted (Estimate)
June 3, 2016
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2015-0191 - Part 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Length-based Weight Estimation
-
University Children's Hospital, ZurichCompletedLength Based Weight EstimationSwitzerland
-
University Children's Hospital, ZurichCompletedWeight-EstimationSwitzerland
-
Ain Shams UniversityUnknownEstimation of Fetal WeightEgypt
-
University Children's Hospital, ZurichCompletedWeight-EstimationSwitzerland
-
Florida Atlantic UniversityNot yet recruitingWeight, Body | Drug Dose | No Specific Conditions | Weight-Estimation
-
University of Alabama at BirminghamCompletedAccuracy of Clinic-based Weight MeasurementsUnited States
-
Hacettepe UniversityRecruitingObesity | Polymorphism, Restriction Fragment LengthTurkey
-
University of MinnesotaCompletedMulticomponent School Based Behavioral Intervention | Prevent Further Weight Gain and or Promote | Weight Loss Among Adolescents
-
Tufts UniversityHelen Keller International; Purdue University; Patan Academy of Health Sciences; Government of Nepal and other collaboratorsCompletedBirth Weight | Stunting | Birth Length | Linear Growth Failure | Height for Age
-
Drexel UniversityCompletedAcceptance-based Treatment | Standard Behavioral TreatmentUnited States
Clinical Trials on Device: Accuracy of a program and the anesthesia tape ("Anästhesie-Lineal")
-
University Children's Hospital, ZurichCompletedWeight-EstimationSwitzerland
-
University Children's Hospital, ZurichCompletedLength Based Weight EstimationSwitzerland
-
Melbourne HealthRecruitingVital Signs | Inpatients | Hospital-at-homeAustralia
-
University of RzeszowDonum Corde Rehabilitation CenterNot yet recruitingNervous System Diseases | Physical Activity | Neurorehabilitation | Biomedical Enhancement
-
Foundation for Innovative New Diagnostics, SwitzerlandUniversity Hospital, Geneva; B.P. Koirala Institute of Health SciencesCompletedDiabetes Mellitus | Chronic Kidney Diseases | HyperlipidemiasNepal
-
Biruni UniversityCompletedOveractive Bladder
-
Vejle HospitalOpen Patient data Explorative NetworkCompletedBreast Cancer | Shoulder Pain | Rehabilitation | Late EffectDenmark
-
King Abdulaziz UniversityNot yet recruiting
-
Hospices Civils de LyonCompletedAnxiety Reduction, Elective Cesarean SectionFrance
-
Bluebird International ClinicNot yet recruiting