Clinical trial NCT02480413: Evaluation of an Algorithm for Length Based Weight Estimation
Official title: Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Pediatric Emergency Tape (Pädiatrisches Notfalllineal - PNL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length Based Weight Estimation
Keywords: Broselow Tape
Weight estimation
Patient safety
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 492
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 anaesthesia

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.

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

Primary outcomes:
measure: length based weight estimation by algorithm
timeFrame: during anaesthesia
Secondary outcomes:
measure: length based age estimation
timeFrame: during anaesthesia
measure: size of endotracheal tube
timeFrame: during anaesthesia
measure: size of laryngeal mask
timeFrame: during anaesthesia
measure: size of facemask
timeFrame: during anaesthesia
measure: size of oropharyngeal tube
timeFrame: during anaesthesia
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Childrens Hospital
Study officials:
affiliation: University Children´s Hospital Zurich
name: Alexander R Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: