Clinical trial NCT02789930: Evaluation of Program for Length Based Weight Estimation
Official title: Evaluation of a Program for Length Based Weight Estimation in Comparison to the Anesthesia Tape ("Anästhesie-Lineal")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length-based Weight Estimation
Body Weights and Measures
Keywords: Weight estimation
Patient safety
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients planned for elecitve surgery in general anesthesia

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").

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.

Eligibility criteria: 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

Primary outcomes:
measure: length-based weight-estimation by program
timeFrame: intraoperative
Secondary outcomes:
measure: length based age estimation
timeFrame: intraoperative
measure: size of endotracheal tube
timeFrame: intraoperative
measure: size of laryngeal mask
timeFrame: intraoperative
measure: size of facemask
timeFrame: intraoperative
measure: size of oropharyngeal tube
timeFrame: intraoperative
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Childrens Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Achim J Schmitz, M.D.
role: STUDY_CHAIR
References: