Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- length-based weight-estimation by algorithm
Study Overview
Brief Summary
The purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the Broselow Tape (BT). 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 BT.
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 BT) will be compared with each other regarding primary and secondary outcome parameters.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •body length suitable with the investigated emergency tapes
- •all patients aged 0 -16 years
- •receiving general anaesthesia with intubation or laryngeal mask
Exclusion Criteria
- •Already included in this study once
- •missing patient or parental consent
Outcomes
Primary Outcomes
length-based weight-estimation by algorithm
Time Frame: during anaesthesia
The by the algorithm estimated bodyweight based on the patient's Body length is investigated regarding the estimations accuracy and cases in the +/- 10% interval
Secondary Outcomes
- size of laryngeal mask(during anaesthesia)
- size of facemask(during anaesthesia)
- size of endotracheal tube(during anaesthesia)
- length based age estimation(during anaesthesia)
- size of oropharyngeal tube(during anaesthesia)