Skip to main content
OpenTrials
Completed

NCT Number: NCT02620540

Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Known Devices

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight-Estimation

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Childrens Hospital

Zurich, 8051, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuracy of an algorithm and the Broselow Tape

Device

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

Primary outcomes

  1. 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

  1. length based age estimation

    Time frame: during anaesthesia

    The by the algorithm estimated age based on the patient's body length is investigated regarding the estimations accuracy

  2. size of endotracheal tube

    Time frame: during anaesthesia

    The by the algorithm suggested endotracheal tube based on the patient's Body length is investigated regarding the correctness

  3. size of laryngeal mask

    Time frame: during anaesthesia

    The by the algorithm suggested laryngeal mask based on the patient's Body length is investigated regarding the correctness

  4. size of facemask

    Time frame: during anaesthesia

    The by the algorithm suggested facemask based on the patient's body length is investigated regarding the correctness

  5. size of oropharyngeal tube

    Time frame: during anaesthesia

    The by the algorithm suggested oropharyngeal tube based on the patient's Body length is investigated regarding the correctness

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.