Weight-EstimationNCT02620540
Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Known Devices
An observational study of Weight-Estimation, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight-Estimation
- What is being tested?
- Accuracy of an algorithm and the Broselow Tape
- Type of treatment
- Medical device
- How many people
- 312 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients planned for elecitve surgery in general anaesthesia
Who may be able to join
- body length suitable with the investigated emergency tapes
- all patients aged 0 -16 years
- receiving general anaesthesia with intubation or laryngeal mask
Who cannot join
- Already included in this study once
- missing patient or parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)
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.
Read the 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.
- Conditions
- Weight-Estimation
- Being tested
- Accuracy of an algorithm and the Broselow Tape
- Keywords
- Broselow Tape, Weight estimation, Patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of an algorithm and the Broselow TapeDevice
Computer based comparison of the two devices based on collected patient data
What is being measured
The primary outcome is the main question the study is designed to answer.
length-based weight-estimation by algorithm
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
Measured: during anaesthesia
Secondary outcomes (5)
length based age estimation
The by the algorithm estimated age based on the patient's body length is investigated regarding the estimations accuracy
Measured: during anaesthesia
size of endotracheal tube
The by the algorithm suggested endotracheal tube based on the patient's Body length is investigated regarding the correctness
Measured: during anaesthesia
size of laryngeal mask
The by the algorithm suggested laryngeal mask based on the patient's Body length is investigated regarding the correctness
Measured: during anaesthesia
size of facemask
The by the algorithm suggested facemask based on the patient's body length is investigated regarding the correctness
Measured: during anaesthesia
size of oropharyngeal tube
The by the algorithm suggested oropharyngeal tube based on the patient's Body length is investigated regarding the correctness
Measured: during anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight-EstimationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620540
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0191 - Part 2
- Status last verified
- May 2018
- First submitted
- 17 Nov 2015
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)
- ClinicalTrials.gov ID
- NCT02620540
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0191 - Part 2
- Conditions
- Weight-Estimation
- Keywords
- Broselow Tape, Weight estimation, Patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients planned for elecitve surgery in general anaesthesia
Key inclusion criteria (3 listed)
- body length suitable with the investigated emergency tapes
- all patients aged 0 -16 years
- receiving general anaesthesia with intubation or laryngeal mask
Key exclusion criteria (2 listed)
- Already included in this study once
- missing patient or parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuracy of an algorithm and the Broselow TapeComputer based comparison of the two devices based on collected patient data | Device | – |
Primary outcome
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
5 secondary outcomes
length based age estimation
Time frame: during anaesthesia
size of endotracheal tube
Time frame: during anaesthesia
size of laryngeal mask
Time frame: during anaesthesia
size of facemask
Time frame: during anaesthesia
size of oropharyngeal tube
Time frame: during anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight-Estimation, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length-based weight-estimation by algorithm (time frame: during anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.